Drug Recall Report - Washington State Local Health Insurance - CHPW

Drug Recall Report

The Drug Recall Report is for prescription drugs that are have recently been issued recalls by the U.S. Food and Drug Administration (FDA). Here’s what you should do if your prescription medications are recalled:
  • Do not continue to use any recalled prescription medicine
  • Contact your provider or pharmacist if you have experienced any reactions.
  • Check your prescription label for the drug lot number and the expiration date to see if any of your medication is affected by the recall.
  • If you have the medication, contact the pharmacy that you received it from. Any adverse actions or events from the use of prescription drugs should be reported to FDA here or calling 1-800-FDA-0178.
Stay up to date with current recall notices by visiting the FDA website.

MIBELAS 24 FE 1MG-20(24)

On August 19, 2020, LUPIN PHARMACEUTICALS recalled MIBELAS 24 FE due to the presence of an impurity. The U.S. Food and Drug Administration (FDA) has issued a CLASS II recall of the affected medications. More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm. The detailed information of the recalled product is listed below: Recalled Drug:   MIBELAS 24 FE 1MG-20(24) NDC Number:   68180091113 Lot Numbers:    L900017, L900070, L900589, L901085, L901008, L901641, L901735 Expiration Date:  12/31/2020, 3/31/2021, 4/30/2021, 6/30/2021, 10/31/2021 What you should do:
  • Do not continue to use MIBELAS 24 FE 1MG-20(24) if it has been recalled.
  • Check your prescription label to see if you any MIBELAS 24 FE in the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from.
  • Adverse events from the use of prescription drugs should be reported to FDA by visiting fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

Metformin ER 500mg and 1000mg tablets (Manufactured by Lupin Pharmaceuticals)

On July 22, 2020, Lupin Pharmaceuticals recalled Metformin ER 750mg and 1000mg due to the presence of an impurity. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications. More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm. The detailed information of the recalled product is listed below: Recalled Drug: Metformin ER 500mg and 1000mg NDC Number: 68180033801, 68180033607, 68180033909, 68180033707 Due to the high volume of Lot numbers affected, please refer to the FDA website link above for specific information regarding the lot number(s) and expiration date(s) related to your medication. What you should do:
  • Do not continue to use Metformin ER 750mg or 1000mg if it has been recalled.
  • Check your prescription label to see if you have any of the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from. Adverse events from the use of prescription drugs should be reported to FDA by visiting fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

Metformin ER 750mg (manufactured by Granules Pharmaceuticals)

On 7/22/2020, Granules Pharmaceuticals recalled Metformin ER due to the presence of an impurity. The U.S. Food and Drug Administration (FDA) has issued a Class II recall of the affected medications. More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm. The detailed information of the recalled product is listed below: Recalled Drug:   Metformin ER NDC Number:     70010-0492-01, 70010-0492-05 Due to the high volume of Lot numbers affected, please refer to the FDA website link above for specific information regarding the lot number(s) and expiration date(s) related to your medication. What you should do:
  • Do not continue to use Metformin ER 750mg if it has been recalled.
  • Check your prescription label to see if you any Metformin ER in the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from.
  • Adverse events from the use of prescription drugs should be reported to FDA by visiting fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

AURYXIA 210MG IRON TABLETS

On July 22, 2020 KERYX BIOPHARMACEUTICALS recalled AURYXIA due to lack of quality assurance as determined by the FDA. The U.S. Food and Drug Administration (FDA) has issued a Class II recall of the affected medications. More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm. The detailed information of the recalled product is listed below: Recalled Drug:   AURYXIA 210MG IRON NDC Number:     59922063101 Due to the high volume of Lot numbers affected, please refer to the FDA website link above for specific information regarding the lot number(s) and expiration date(s) related to your medication. What you should do:
  • Do not continue to use AURYXIA 210MG IRON if it has been recalled.
  • Check your prescription label to see if you have any AURYXIA in the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from.
  • Adverse events from the use of prescription drugs should be reported to FDA by visiting fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

LISINOPRIL 10 MG

On August 5, 2020, BLUEPOINT LABORATORIES recalled LISINOPRIL 10 MG due to a possible tablet mix-up. The U.S. Food and Drug Administration (FDA) has issued a Class II of the affected medications. More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm. The detailed information of the recalled product is listed below: Recalled Drug:LISINOPRIL 10 MG NDC Number:68001033408 Lot Numbers:  Q000232 Expiration Date:  01/2022 What you should do:
  • Do not continue to use LISINOPRIL 10 MG if it has been recalled
  • Check your prescription label to see if you have any LISINOPRIL in the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from. Adverse events from the use of prescription drugs should be reported to FDA by visiting fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

Metformin ER 500mg and 750mg

multiple manufactuers are recalling Metformin 500mg and 700mg Extended Release Tablets due to the presence of an impurity. The U.S. Food and Drug Administration (FDA) has issued a Class II recall of the affected medications. More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm. The detailed information of the recalled product is listed below: Recalled Drug: Metformin ER 500mg and 750mg NDC Number: Due to the high volume of NDC numbers affected, please refer to the FDA website link above for specific information regarding the NDC(s), lot number(s) and expiration date(s) related to your medication. What you should do:
  • Do not continue to use any medication that has been recalled.
  • Check your prescription label to see if you have Metformin ER 500mg or 750mg in the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from.
  • Adverse events from the use of prescription drugs should be reported to FDA by visiting fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

NP Thyroid 30mg, 60mg, 90mg

On June 10, 2020, Acella Pharmaceuticals, LLC, recalled NP Thyroid due to sub-potency. The U.S. Food and Drug Administration (FDA) has issued a Class I recall of the affected medications. More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm. The detailed information of the recalled product is listed below: Recalled Drug:               NP Thyroid 30mg, 60mg, 90mg NDC Numbers:              42192032901, 42192033001, 42192033101 Lot Numbers:                M329H18-1, M329J18-1, M329J18-2, M329J18-3, M329M18-2, M329A19-1, M330J18-2A, M330J18-3, M331G18-1, M331J18-1, M331J18-2, M331M18-1, M331M18-2 Expiration Dates:          JUN-2020, JUL-2020, AUG-2020, NOV-2020, DEC-2020 What you should do:
  • Do not continue to use NP Thyroid if it has been recalled.
  • Check your prescription label to see if you have any of the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from.
  • Adverse events from the use of prescription drugs should be reported to FDA by visiting fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

Mirtazapine 15mg tablets

On April 22, 2020, Aurobindo Pharma USA, Inc., recalled MIRTAZAPINE 15mg tablets due to the possibility of contamination. The U.S. Food and Drug Administration (FDA) has issued a Class II recall of the affected medications. More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm. The detailed information of the recalled product is listed below: Recalled Drug:               Mirtazapine 15mg NDC Number:                13107-0031-34, 65862-0198-99 Lot Numbers:                 031180028A Expiration Date:            03/2021 What you should do:
  • Do not continue to use MIRTAZAPINE 15mg if it has been recalled.
  • Check your prescription label to see if you have any of the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from. Adverse events from the use of prescription drugs should be reported to FDA by visiting fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

Oxycodone/acetaminophen 10/325mg tablets

On April 22, 2020, Aurobindo Pharma USA, Inc., recalled OXYCODONE/ACETAMINOPHEN 10/325mg tablets due to the possibility of contamination. The U.S. Food and Drug Administration (FDA) has issued a Class II recall of the affected medications. More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm. The detailed information of the recalled product is listed below: Recalled Drug:               Oxycodone/acetaminophen 10/325mg NDC Number:                13107-0046-01 Lot Numbers:                 046180056A Expiration Date:            05/2020 What you should do:
  • Do not continue to use OXYCODONE/ACETAMINOPHEN if it has been recalled.
  • Check your prescription label to see if you have any of the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from. Adverse events from the use of prescription drugs should be reported to FDA by visiting fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

Mirtazapine 15mg tablets

On April 22, 2020, Aurobindo Pharma USA, Inc., recalled MIRTAZAPINE 15mg tablets due to the possibility of contamination. The U.S. Food and Drug Administration (FDA) has issued a Class II recall of the affected medications. More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm. The detailed information of the recalled product is listed below: Recalled Drug:               Mirtazapine 15mg NDC Number:                13107-0031-34, 65862-0198-99 Lot Numbers:                 031180028A Expiration Date:            03/2021 What you should do:
  • Do not continue to use MIRTAZAPINE 15mg if it has been recalled.
  • Check your prescription label to see if you have any of the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from. Adverse events from the use of prescription drugs should be reported to FDA by visiting fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

LISINOPRIL 30 MG

On April 8, 2020, LUPIN PHARMACEUTICALS, INC. recalled LISINOPRIL due to the possibility of a tablet mix-up. The U.S. Food and Drug Administration (FDA) has issued a Class II recall of the affected medications. More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm. The detailed information of the recalled product is listed below: Recalled Drug:               LISINOPRIL 30 MG NDC Number:                68180098201 Lot Numbers:                Q900580 Expiration Date:            9/2021 What you should do:
  • Do not continue to use LISINOPRIL 30 MG if it has been recalled.
  • Check your prescription label to see if you any of the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from.
  • Adverse events from the use of prescription drugs should be reported to FDA by visiting fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

Levetiracetam 750mg tablets

On April 22, 2020, Aurobindo Pharma USA, Inc., recalled LEVETIRACETAM 750mg due to the possibility of contamination. The U.S. Food and Drug Administration (FDA) has issued a Class II recall of the affected medications. More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm. The detailed information of the recalled product is listed below: Recalled Drug:     Levetiracetam 750mg NDC Number:    65862-0053-90 Lot Numbers:      24719001A1 Expiration Date:   03/2021 What you should do:
  • Do not continue to use LEVETIRACETAM 750mg if it has been recalled
  • Check your prescription label to see if you have any of the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from. Adverse events from the use of prescription drugs should be reported to FDA by visiting fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

GLYCOPYRROLATE 1 MG

On April 8, 2020, PAR PHARM. recalled GLYCOPYRROLATE 1 MG due to the presence of an impurity. The U.S. Food and Drug Administration (FDA) has issued a Class II recall of the affected medications. More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm. The detailed information of the recalled product is listed below: Recalled Drug:  GLYCOPYRROLATE 1 MG NDC Number:   49884006501 Lot Numbers:    32809101 Expiration Date:  3/2021 What you should do:
  • Do not continue to use GLYCOPYRROLATE 1 MG if it has been recalled
  • Check your prescription label to see if you any of the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from. Adverse events from the use of prescription drugs should be reported to FDA by visiting fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

Gabapentin 100mg Capsule

On April 22, 2020, Aurobindo Pharma USA, Inc., recalled GABAPENTIN 100mg due to the possibility of contamination. The U.S. Food and Drug Administration (FDA) has issued a Class II recall of the affected medications. More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm. The detailed information of the recalled product is listed below: Recalled Drug:               Gabapentin 100mg NDC Number:                65862-0198-99 Lot Numbers:                 198180048A, 198180061A, 19819017A1 Expiration Date:            04/2021, 06/2020, 02/2021 What you should do:
  • Do not continue to use GABAPENTIN 100mg if it has been recalled
  • Check your prescription label to see if you have any of the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from. Adverse events from the use of prescription drugs should be reported to FDA by visiting fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

Daytrana (methylphenidate) 10mg, 20mg, and 30mg patches

On April 29, 2020, Noven Therapeutics, LLC, recalled Daytrana 10mg, 20mg, and 30mg patches due to the possibility of the patch being defective. The U.S. Food and Drug Administration (FDA) has issued a Class II recall of the affected medications. More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm. The detailed information of the recalled product is listed below: Recalled Drug:  Daytrana 10mg, 20mg, and 30mg NDC Number: 68968-5552-03, 68968-5554-03, 68968-5555-03 Lot Numbers:  886647, 86354, 86355, 86356, 86550, 87348, 87965 Expiration Date: 09/2020, 08/2020, 07/2020, 08/2020, 07/2020, 01/2021. 01/2021 What you should do:
  • Do not continue to use DAYTRANA 10mg, 20mg, and 30mg if it has been recalled.
  • Check your prescription label to see if you have any of the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from. Adverse events from the use of prescription drugs should be reported to FDA by visiting fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

Acetaminophen with Codeine 300/15mg, 300/30mg, 300/60mg

On April 8, 2020, Aurobindo Pharma, USA, Inc., recalled acetaminophen with codeine due to possible contamination. The U.S. Food and Drug Administration (FDA) has issued a Class II recall of the affected medications. More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm. The detailed information of the recalled product is listed below: Recalled Drug:               Acetaminophen with Codeine 300/15mg, 300/30mg, 300/60mg NDC Number:                13107005801, 13107005999, 13107006001, 52959000310, 52959000312,                                                              52959000314, 52959000316, 52959000320, 52959000330, 52959000360 Lot Numbers:                058180015A, 058180016A, 05818017B1, 059180023A, 059180024A, 059180025A,                                                     060180017A, 060180019B1, 060180020A and 060180021A Expiration Date:            07/2021, 09/2021, 05/2021, 06/2021 What you should do:
  • Do not continue to use any of the affected drug if it has been recalled.
  • Check your prescription label to see if you have any of the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from.
  • Adverse events from the use of prescription drugs should be reported to FDA by visiting fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

Daytrana (methylphenidate) 10mg, 15mg, 20mg, and 30mg patches

On March 25, 2020, Noven Therapeutics Associates, Inc., recalled Daytrana due to the possibility of the patch being defective. The U.S. Food and Drug Administration (FDA) has issued a Class II recall of the affected medications. More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm. The detailed information of the recalled product is listed below: Recalled Drug:            Daytrana Patches (all strengths) NDC Number(s):        68968555203, 68968555303, 68968555403, 68968555503 Lot Number(s):           86280, 85942, 86281, 86081, 86196, 86083, 86282 Expiration Date:         06/2020, 03/2020, 06/2020, 04/2020, 05/2020, 06/2020 What you should do:
  • Do not continue to use the medication if it has been recalled.
  • Check your prescription label to see if you have any of the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from.
  • Adverse events from the use of prescription drugs should be reported to FDA by visiting fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

Sotalol AF 80mg

On March 25, 2020, Mylan Pharmaceuticals recalled Sotalol due to the presence of an impurity. The U.S. Food and Drug Administration (FDA) has issued a Class II recall of the affected medications. More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm. The detailed information of the recalled product is listed below: Recalled Drug:         Sotalol AF 80mg NDC Number:            00378512301 Lot Number:              3095754 Expiration Date:     02/2021 What you should do:
  • Do not continue to use the medication if it has been recalled.
  • Check your prescription label to see if you have any of the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from.
  • Adverse events from the use of prescription drugs should be reported to FDA by visiting fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

Phenytoin 125mg/5mL oral suspension

On February 21, 2020, Taro Pharmaceuticals, USA, Inc., recalled Phenytoin 125mg/5mL due to potency concerns. This is a voluntary recall from the manufacturer, therefore, it is being treated as a Class I Recall. More information about the recall is at: FDA website. The detailed information of the recalled product is listed below: Recalled Drug:                Phenytoin 15mg/5mL NDC Number:                 51672-4069-01 Lot Numbers:                   327874, 327876 Expiration Date:             December 2020 What you should do:
  • Do not continue to use the medication if it has been recalled.
  • Check your prescription label to see if you have some of the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from. Adverse events from the use of prescription drugs should be reported to FDA by visiting fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

Ranitidine 150mg and 300mg Tablets

On January 15, 2020, Glenmark Pharmaceuticals recalled Ranitidine Tablets due to the presence of an impurity. The U.S. Food and Drug Administration (FDA) has issued a Class II recall of the affected medications. More information about the recall is at: FDA website. The detailed information of the recalled product is listed below: Recalled Drug:                Ranitidine 150mg and 300mg Tablets NDC Number(s):            68462024860, 68462024801, 68462024930, 68462024901, 68462024920,                                                              68462024805, 70518171400, 65162025310 Due to the high number of lot numbers affected, please refer to the FDA website link above for specific information regarding the lot number related to your medication. What you should do:
  • Do not continue to use the medication if it has been recalled.
  • Check your prescription label to see if you have any of the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from.
  • Adverse events from the use of prescription drugs should be reported to FDA by visiting fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

Lamotrigine 100mg Tablet

On January 10, 2020, Taro Pharmaceuticals U.S.A., Inc., recalled LAMOTRIGINE 100MG due to a possible cross-contamination. The U.S. Food and Drug Administration (FDA) has not yet issued recall of the affected medications, however, the company has voluntarily recalled the below affected lot number at the consumer level. More information about the recall is at: https://www.fda.gov/drugs/drugsafety/drugRecalls/default.htm The detailed information of the recalled product is listed below: Recalled Drug:                Lamotrigine 100mg NDC Number:                 51672-4131-01 Lot Number(s):               331771 Expiration Date:             June, 2021 What you should do:
  • Do not continue to use Lamotrigine 100mg if it has been recalled.
  • Check your prescription label to see if you have any of the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from.
  • Adverse events from the use of prescription drugs should be reported to FDA by visiting fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

Blisovi FE 1.5/30mg, 21 Tablets per pack

On January 15, 2020, Lupin Pharmaceuticals recalled Blisovi FE due to complaints related to crumbling of tablets when popped out of the blister pack. The U.S. Food and Drug Administration (FDA) has issued a Class II recall of the affected medications. More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm. The detailed information of the recalled product is listed below: Recalled Drug:                BLISOVI FE 1.5-30(21) NDC Number:                 68180086611 Lot Number(s):               H801227 Expiration Date:             January, 2020 What you should do:
  • Do not continue to use this drug if it has been recalled.
  • Check your prescription label to see if you have any of the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from.
  • Adverse events from the use of prescription drugs should be reported to FDA by visiting fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

Nystatin Oral Suspension 10,000 units per mL

On February 5, 2020, Pharmaceutical Associates, Inc., recalled Nystatin Oral Suspension 10,000 units per mL due to possible sub-potency issues. The U.S. Food and Drug Administration (FDA) has issued a Class II recall of the affected medications. More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm. The detailed information of the recalled product is listed below: Recalled Drug:                NYSTATIN 100000/ML NDC Number:                 00121081016 Lot Numbers:                   BB70, BB71 Expiration Date:             May 2020 What you should do:
  • Do not continue to use this medication if it has been recalled
  • Check your prescription label to see if you have any of the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from. Adverse events from the use of prescription drugs should be reported to FDA by visiting fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

Ranitidine

On December 9, 2019, Amneal Pharmaceuticals, Inc., recalled Ranitidine 150mg and 350mg tablets, as well as Ranitidine 15mg/mL oral solution, due to the presence of an impurity. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications. More information about the recall is available on the FDA website. The detailed information of the recalled product is listed below: Recalled Drug:                 Ranitidine 150mg, 300mg tablets, 15mg/mL oral solution NDC Number:                  65162-253-06, 65162-253-10, 65162-253-18, 65162-253-50, 65162-253-11, 65162-254-30, 65162-254-10, 65162-254-25, 65162-664-90 Due to the high volume of Lot numbers affected, please refer to the FDA website link above for specific information regarding the lot number related to your medication. What you should do:
  • Do not continue to use the medication if it has been recalled.
  • Check your prescription label to see if you have any of the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from.
  • Adverse events from the use of prescription drugs should be reported to FDA by visiting fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

View past recalls still in effect:

Levetiracetam Oral Solution 100mg/mL
On December 27, 2019, Lanett Company, Inc. recalled Levetiracetam 100mg/mL due to contamination. The U.S. Food and Drug Administration (FDA) has issued a Class I Recall of the affected medications. More information about the recall is available on the FDA website. The detailed information of the recalled product is listed below: Recalled Drug:                 LEVETIRACETAM 100mg/mL NDC Number:                  54838054880 Lot Numbers:                    2190A, 2191A Expiration Date:              07/2021
Relpax 40mg Tablet
On 10/14/2019, Pfizer Inc. recalled Relpax 40mg tablets due to potential microbial contamination of non-sterile products. The U.S. Food and Drug Administration (FDA) has issued a recall of the affected medications. More information about the recall is available on the FDA website. The detailed information of the recalled product is listed below: Recalled Drug:                 Relpax 40mg Tablet NDC Number:                  0049-2340-45, 0049-2340-05 Lot Numbers:                   AR5407, CD4565 Expiration Date:              02/22
Ranitidine Hydrochloride (HCL)
On 09/23/2019, SANDOZ recalled RANITIDINE HCL due to the presence of an impurity. The U.S. Food and Drug Administration (FDA) has issued a Class II recall of the affected medications. More information about the recall is available on the FDA website. The detailed information of the recalled product is listed below: Recalled Drug:                 Ranitidine 150mg and Ranitidine 300mg NDC Number:                  00781285560, 00781286531 Lot Numbers:                  HD8625, HD9275, HU2207, HX6676, HX6677, HC9266, HD1865, HP9441, JK7994, JK8659, HD1862, HP9438, HP9439, HP9440 Expiration Date:             4/30/2020, 4/30/2020, 8/31/2020, 3/31/2021, 3/31/2021, 4/30/2020, 4/30/2020, 9/30/2020, 8/31/2021, 8/31/2021, 4/30/2020, 9/30/2020, 9/30/2020, 9/30/2020
Losartan Potassium/Hydrochlorothiazide
On 9/19/2019, Torrent Pharma, Inc., recalled Losartan Potassium (all strengths) and Losartan Potassium/Hydrochlorothiazide (all strengths) due to the presence of an impurity. The U.S. Food and Drug Administration (FDA) has issued a Class II Recall of the affected medications. More information about the recall is available on the FDA website. The detailed information of the recalled product is listed below: Recalled Drug:                 Losartan Potassium and Losartan Potassium/Hydrochlorothiazide NDC Number:                  13668-409-10, 13668-115-90, 13668-115-10, 13668-116-90, 13668-118-90 Lot Numbers:                  4DU2E009, 4DU3E009, 4DU3D018, BEF7D051, 4P04D007 Expiration Date:             12/31/2020, 02/28/2021
Clobazam Oral Suspension 2.5mg/mL
On 7/16/2019, Bionpharma, Inc. recalled Clobazam Oral Suspension 2.5mg/mL due to out-of-specification results for Microbial Enumeration Tests. The U.S. Food and Drug Administration (FDA) has issued a Class II recall of the affected medications. More information about the recall can be found on the FDA website. The detailed information of the recalled product is listed below: Recalled Drug:                 Clobazam Oral Suspension 2.5mg/mL NDC Number:                  69452-116-45 Lot Numbers:                  18246 Expiration Date:             09/2020 Hydrocodone/Chlorpheniramine 10/8mg/5ml On 07/11/2019, Tris Pharma, Inc. recalled Hydrocodone/Chlorpheniramine 10/8mg/5mL due to incorrect potency. The U.S. Food and Drug Administration (FDA) has issued a Class II recall of the affected medications. More information about the recall can be found on the FDA website. The detailed information of the recalled product is listed below: Recalled Drug:                 Hydrocodone/Chlorpheniramine 10/8mg/5mL NDC Number:                  27808-086-02 Lot Numbers:                  14079 Expiration Date:             10/2021 
Losartan
On 5/3/2019, Heritage Pharmaceuticals Inc. and Torrent Pharma Inc. recalled Losartan 25mg, 50mg, 100mg tablets due the presence of an impurity. The U.S. Food and Drug Administration (FDA) has issued a Recall Class II of the affected medications. On 2/28/2019, Camber Pharmaceuticals Inc. recalled Losartan 25mg, 50mg, 100mg tablets due the presence of an impurity. The U.S. Food and Drug Administration (FDA) has issued a Recall Class II of the affected medications. On 4/10/2019, Torrent Pharma, Inc. recalled Losartan potassium tablets due to the presence of an impurity. The U.S. Food and Drug Administration (FDA) has issued a Recall Class II of the affected medications. More information about the recall is at: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=171978 The detailed information of the recalled product is listed below: Recalled drug: Losartan 25mg, 50mg, 100 mg tablets | Losartan Potassium Tablets (all strengths) NDC numbers: 31722070010, 31722070130, 31722070290 Lot numbers: Due to the high volume of lot numbers affected, please refer to the FDA website link above for specific information regarding the lot number related to your medication.
Acyclovir 400mg tablets
On 4/25/2019, Zydus Pharmaceuticals recalled Acyclovir 400mg tablets due to a tablet mix-up. The U.S. Food and Drug Administration (FDA) has issued a Recall Class II of the affected medications. More information about the recall is at: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=172494 The detailed information of the recalled product is listed below: Recalled drug:  Acyclovir 400mg tablets, 100 count bottles NDC number:  68382079101 Lot numbers: Z804517 Expiration date: 11/30/2020
Fentanyl Transdermal Patch, 12mcg/hr
On 4/19/2019, Alvogen, Inc recalled Fentanyl 12mcg/hr transdermal patches due to a packaging mix-up leading to the incorrect strength in respective boxes. The U.S. Food and Drug Administration (FDA) has issued a Recall Class I of the affected medications. More information about the recall is at: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=172322 The detailed information of the recalled product is listed below: Recalled drug: Fentanyl 12mcg/hr transdermal patch NDC number: 47781042347 Lot numbers and expiration date: Lot#: 180060, Exp 05/2020; 180073, Exp 06/2020.
Drospirenone and Ethinyl Estradiol Tablets 3mg/0.03mg
On 3/1/2019, Apotex Inc. recalled Drospirenone and Ethinyl Estradiol Tablets 3mg/0.03mg due to a tablet mix-up. The U.S. Food and Drug Administration (FDA) has issued a Recall Class II of the affected medications. More information about the recall is available on the FDA website. The detailed information of the recalled product is listed below: Recalled Drug:                 Drospirenone and Ethinyl Estradiol Tablets 3mg/0.03mg NDC Number:                  60505418303 Lot Numbers:                  7DY008A, 7DY009A, 7DY010A, 7DY011A Expiration Date:             08/2020 
Irbesartan 300 mg Tablets
On 1/18/2019, Prinston Pharmaceutical Inc. recalled Irbesartan 300mg Tablets due the presence of an impurity. The U.S. Food and Drug Administration (FDA) has issued a Recall Class II of the affected medications. More information about the recall is at: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=170280 The detailed information of the recalled product is listed below: Recalled Drug: Irbesartan 300mg Tablets NDC Number: 43547-376-09 Lot Numbers: 331B18009
Quetiapine Fumarate 400mg
On November 14, 2018, ASCEND LABORATORIES recalled QUETIAPINE FUMARATE 400 MG due to the presence of a foreign substance. The U.S. Food and Drug Administration (FDA) has issued a Recall Class II of the affected medications. This is an ongoing FDA drug recall. Recalled Drug: Quetiapine Fumarate 400mg NDC Number: 67877024801 Lot Number: 7143908 Expiration Date: November 2020
Valsartan, Valsartan-Hydroclorothiazide & Amlodipine-Valsartan
On 1/18/2019, Aurobindo Pharma USA Inc. recalled Valsartan 160mg, 320mg, 40mg, 80mg tablets due the presence of an impurity. The U.S. Food and Drug Administration (FDA) has issued a Recall Class II of the affected medications. On November 20, 2018 Mylan recalled Amlodipine-Valsartan &  Valsartan due to the detection of trace amounts of the impurity NDEA (N-Nitrosodiethylamine) found in the active pharmaceutical ingredient of Valsartan. The U.S. Food and Drug Administration (FDA) has issued a Recall Class II of the affected medications. More information about the recall is available on the FDA website. Recalled Drug: 
  • Valsartan 40 mg, 60 mg, 80 mg, 160 mg, and 320 mg
  • Amlodipine-Valsartan 5/160 mg, 10/160 mg and 10/320 mg
  • Valsartan-Hydrochlorathiazide 320/25 MG
NDC Number: 65862057290, 65862057390, 65862057030, 65862057190, 00378-1721-93, 00378-1722-93, 00378-1724-93, 00378-5813-77, 00378-5814-77, 00378-5807-93, 0378-5815-77 and 0378-6325-05 Lot Number: 3079500, 3061986, 3079709, 3077618, 3079708, 3063782, 3071352, 3061169, 3081499, 3080009, 3080010, 3079205, 3084886, 3093804 Expiration Date:  November 2018, January 2019, March 2019, July 2019, November 2019, December 2019, January 2020, February 2020, March 2020
Tizanidine HCL 2 mg
On 09/04/2018, Dr. Reddy’s Lab recalled Tizanidine HCL 2 MG due to a tablet mix-up. Glimepiride tablets were found in bottles of Tizanidine.  The U.S. Food and Drug Administration (FDA) has issued a Recall Class II of the affected medication. Recalled Drug: Tizanidine HCL 2 mg NDC Number: 55111017915 Lot Numbers: T800304 Expiration Date: 03/2021
Diphenoxylate & Atropine 2.5 mg/0.025mg
On January 4, 2018, Pfizer Inc. recalled Diphenoxylate and Atropine 2.5 mg/0.025mg (NDC# 59762-1061-01 and 59762-1061-02) due to weight variations resulting in tablets that are the incorrect strength. The U.S. Food and Drug Administration (FDA) has issued a Recall Class #1 of the affected medications. Recalled Drug: Diphenoxylate and Atropine 2.5 mg/0.025mg NDC Number: 59762-1061-01 and 59762-1061-02 Lot Number: R83962, R93347, R93348, R93349, R93350, R93351, R93352, R93356, R93357, R93358, R97310, S57831, S57832, S57834 Expiration Date: 2021 OCT 31, 2021 NOV 30
Fluticasone 50mcg
On 05/31/2018, Apotex Corp recalled Fluticasone 50mcg due to the potential presence of embedded and loose particles within the medication. The U.S. Food and Drug Administration (FDA) has issued a Class 2 recall of the affected medications. Recalled Drug: Fluticasone 50mcg NDC Number: 60505-0829-01 Lot Number: NJ4501 Expiration Date: 07/2020
Diphenoxylate and Atropine 2.5 mg/0.025mg
On January 4, 2018, Pfizer Inc. recalled Diphenoxylate and Atropine 2.5 mg/0.025mg (NDC# 59762-1061-01 and 59762-1061-02) due to weight variations resulting in tablets that are the incorrect strength. The U.S. Food and Drug Administration (FDA) has issued a Recall Class #1 of the affected medications. More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm. The detailed information of the recalled product is listed below: Recalled Drug: Diphenoxylate and Atropine 2.5 mg/0.025mg NDC Number: 59762-1061-01 and 59762-1061-02 Lot Number: R83962, R93347, R93348, R93349, R93350, R93351, R93352, R93356, R93357, R93358, R97310, S57831, S57832, S57834 Expiration Date: Oct 31, 2021, Nov 30, 2021

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