RANITIDINE HCL 75MG TABLETS

On October 1, 2019, Dr. Reddy’s Lab recalled Ranitidine 75mg 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: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=177635

The detailed information of the recalled product is listed below:

Recalled Drug: Ranitidine HcL 75mg tablets
NDC Number:  55111013160
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 ranitidine 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 https://www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

RANITIDINE HYDROCHLORIDE (HCL) 150MG
RANITIDINE HYDROCHLORIDE (HCL) 300MG

On September 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 at: https://www.accessdata.fda.gov/scripts/ires/index.cfm

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

What you should do:

  • Do not continue to use RANITIDINE HCL if it has been recalled.
  • Check your prescription label to see if you have RANITIDINE HCL 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 www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

LOSARTAN POTASSIUM
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 at: https://www.accessdata.fda.gov/scripts/ires/index.cfm

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

What you should do:

  • Do not continue to use Losartan Potassium or Losartan Potassium/Hydrochlorothiazide if it has been recalled.
  • Check your prescription label to see if you have Losartan Potassium or Losartan Potassium/Hydrochlorothiazide 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 www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

VALSARTAN,  VALSARTAN-HYDROCLOROTHIAZIDE & AMLODIPINE- VALSARTAN

On 12/31/2018, Aurobindo Pharma USA, Inc. recalled Amlodipine-Valsartan, Valsartan-HCTZ, and Valsartan tablets due to the detection of trace amounts of an unexpected impurity found in the finished drug product.   To date, Aurobindo Pharma USA, Inc. has not received any reports of adverse events related to this recall. The U.S. Food and Drug Administration (FDA) has issued a Recall Class #2 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: Valsartan 320mg tablets, Amlodipine-Valsartan 5/160mg, 5/320mg, 10/160mg,    10/320mg tablets , and Valsartan & Hydrochlorothiazide 80/12.5mg, 160/12.5mg, 160/25mg, 320/12.5mg and 320/25mg tablets

Lot Numbers: Aurobindo Pharma USA, Inc. has 80 different lots of medications affected in this recall. Please refer to the link above for more information on the National Drug Code (NDC), expiration date and lot number that corresponds with your medication.

What you should do:

  • Check your prescription label to see if you have medication of the affected lot numbers and expiration dates.
  • Contact your pharmacist or physician if you have experienced any adverse reactions.
  • 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 www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

QUETIAPINE FUMARATE 400 MG

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.

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: QUETIAPINE FUMARATE 400 MG

NDC Number: 67877024801

Lot Number: 7143908

Expiration Date: November 2020

What you should do

  • Do not continue to use QUETIAPINE FUMARATE 400 MG if it has been recalled
  • Check your prescription label to see if you have QUETIAPINE FUMARATE 400 MG 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 www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

VALSARTAN, AMLODIPINE-VALSARTAN and VALSARTAN-HYDROCHLORATHIAZIDE

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 at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

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: 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

What you should do

  • Do not continue to use VALSARTAN, AMLODIPINE-VALSARTAN and VALSARTAN-HYDROCHLORATHIAZIDE if it has been recalled
  • Check your prescription label to see if you have VALSARTAN, AMLODIPINE-VALSARTAN and VALSARTAN-HYDROCHLORATHIAZIDE 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 www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

TIZANIDANE 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.  

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: TIZANIDINE HCL 2 MG

NDC Number: 55111017915

Lot Numbers: T800304

Expiration Date: 03/2021

What you should do:

  • Do not continue to use TIZANIDINE HCL 2 MG if it has been recalled
  • Check your prescription label to see if you have TIZANIDINE HCL 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 www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

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.

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: 2021 OCT 31, 2021 NOV 30

What you should do

  • Do not continue to use Diphenoxylate and Atropine 2.5 mg/0.025mg if it has been recalled
  • Check your prescription label to see if you have Diphenoxylate and Atropine 2.5 mg/0.025mg 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 www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

VALSARTAN & VALSARTAN HYDROCHLOROTHIAZIDE

On July 17, 2018, Actavis, Major Pharmaceuticals, and Prinston Pharmaceutical Inc. (Solco Healthcare LLC), recalled Valsartan and Valsartan Hydrochlorothiazide due to the detection of a trace amount of unexpected impurity, carcinogen N-nitrosodimethylamine (NDMA). The U.S. Food and Drug Administration (FDA) has not issued a recall classification of the affected medications at this time.

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: Valsartan and Valsartan Hydrochlorothiazide

Drug Strength: Valsartan: 40 mg, 80mg, 160mg, and 320mg. Valsartan Hydrochlorothiazide: 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, and 320mg/25mg

*Due to the high volume of NDC and Lot numbers affected, please refer to the FDA website link above for specific information related to the manufacturer of your medication.

What you should to:

  • Do not continue to use Valsartan or Valsartan Hydrochlorothiazide if it has been recalled.
  • Check your prescription label to see if you have Valsartan or Valsartan Hydrochlorothiazide 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 www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

NALOXONE HYDROCHLORIDE INJECTION

On 06/04/2018, Hospira, Inc. recalled Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL, and Carpuject Single-use cartridge syringe system 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 1 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: Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL and Carpuject Single-use cartridge syringe system

NDC Number: 00409-1782-03 and 00409-1782-69

Lot Number: 72680LL and 76510LL

Expiration Date: 12/1/2018 and 4/1/2019

What you should do:

  • Do not continue to use Naloxone Hydrochloride Injection if it has been recalled.
  • Check your prescription label to see if you have Naloxone Hydrochloride 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 www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178

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.

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: Fluticasone 50mcg

NDC Number: 60505-0829-01

Lot Number: NJ4501

Expiration Date: 07/2020

What you should do:

  • Do not continue to use Fluticasone 50mcg if it has been recalled.
  • Check your prescription label to see if you have Fluticasone 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 www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

METOPROLOL SUCCINATE 100 MG

On 05/09/2018 Dr. Reddy's Laboratories recalled METOPROLOL SUCCINATE 100 MG due to due to tablet mix- up. Clopidogrel tablets were found in bottles of Metoprolol. The U.S. Food and Drug Administration (FDA) has issued a Recall Class #2 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:       METOPROLOL SUCCINATE 100 MG

NDC Number:        55111-0468-01

Lot Number:          C706254

Expiration Date:    08/2019

What you should do:

  • Do not continue to use METOPROLOL SUCCINATE 100 MG if it has been recalled
  • Check your prescription label to see if you have METOPROLOL 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 www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

FLUOXETINE HCL 10 MG Tablet

On 2/5/2018, Teva Pharmaceuticals IND recalled Lot # 732259, 732260, 732261, 732262, 732263, 732264, 732265, 732266, 732267, 732268, 732269, 732270, 732272, 732273, 732274, 732275, 732276, 732277, 732278, 732280, 732281, 732282, 732283, 732284, 732285, 732286, 732287, 732288, 732289, 732293, 732294, 732296, 732297, 732295, 732298, 732299, 732300, 732301 of FLUOXETINE HCL 10 MG

NDC# 00093718856 due to errors in the manufacturing process. The U.S. Food and Drug Administration (FDA) has issued an unclassified 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:                FLUOXETINE HCL 10 MG Tablet
NDC Number:                 00093718856
Lot Numbers:                  732259, 732260, 732261, 732262, 732263, 732264, 732265, 732266, 732267, 732268,

                                          732269, 732270, 732272, 732273, 732274, 732275, 732276, 732277, 732278, 732280,

                                            732281, 732282, 732283, 732284, 732285, 732286, 732287, 732288, 732289, 732293,

                                            732294, 732296, 732297, 732295, 732298, 732299, 732300, 732301
Expiration Date:               All lots within expiry

What you should do:

  • Do not continue to use FLUOXETINE HCL if it has been recalled.
  • Check your prescription label to see if you have FLUOXETINE HCL 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 www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

CLOPIDOGREL 75 MG

On 01/04/2018, International Laboratories LLC recalled Lot Number 117099A of CLOPIDOGREL 75 MG. (NDC# 54458-0888-16) due to a labeling mix-up. Simvastatin tablets found in bottles labeled as Clopidogrel tablets. 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: CLOPIDOGREL 75 MG
NDC Number: 54458-0888-16
Lot Numbers: 117099A
Expiration Date: Exp. 08/19

What you should do:

  • Do not continue to use CLOPIDOGREL 75 MG if it has been recalled
  • Check your prescription label to see if you have CLOPIDOGREL 75 MG 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 www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178. 

PRAVASTATIN SODIUM 10 & 20 MG

On 01/12/2018, International Laboratories LLC., recalled Lot Numbers 1117093A and 117103A of PRAVASTATIN SODIUM 10 & 20 MG tablets (NDC# 54458-0927-16 and 54458-0926-16) due to a tablet mix-up. Bottles of medication could contain Pravastatin 10 mg and 20 mg tablets in the same bottle. The U.S. Food and Drug Administration (FDA) has issued a Recall Class #2 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: Pravastatin 10 and 20mg

NDC Number: 54458-0927-16 and 54458-0926-16

Lot Numbers: 1117093A and 117103A

Expiration Date: Exp. 06/19 and Exp. 03/19

What you should do:

  • Do not continue to use PRAVASTATIN SODIUM if it has been recalled
  • Check your prescription label to see if you have PRAVASTATIN SODIUM 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 www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

Divalproex Sodium DR 500 MG

On 01/17/2018, Unichem Pharmaceuticals USA Inc. recalled Lot Number ZDPH17040 of Divalproex Sodium DR 500 MG (NDC# 29300-0140-01) due to presence of an anti-fungal agent (metronidazole powder) found in one bottle. 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: Divalproex Sodium DR 500 MG
NDC Number: 29300-0140-01
Lot Numbers: ZDPH17040
Expiration Date: N/A

What you should do:

  • Do not continue to use Divalproex Sodium DR 500 MG if it has been recalled.
  • Check your prescription label to see if you have Divalproex Sodium DR 500 MG 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 www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178. 

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: 2021 OCT 31, 2021 NOV 30

What you should do:

Do not continue to use Diphenoxylate and Atropine 2.5 mg/0.025mg if it has been recalled. Check your prescription label to see if you have Diphenoxylate and Atropine 2.5 mg/0.025mg 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 www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.