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Showing posts with the label Drug Recalls

FDA Alert: Lupin Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Four Lots of Quinapril Tablets Due to Potential Presence of N-Nitroso-Quinapril Impurity

FDA Alert: Lupin Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Four Lots of Quinapril Tablets Due to Potential Presence of N-Nitroso-Quinapril Impurity

Aurobindo Pharma USA, Inc. Initiates Voluntary Nationwide Recall of Two (2) Lots of Quinapril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, Due to the Detection of N-Nitroso Quinapril Impurity | FDA

Aurobindo Pharma USA, Inc. Initiates Voluntary Nationwide Recall of Two (2) Lots of Quinapril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, Due to the Detection of N-Nitroso Quinapril Impurity | FDA : East Windsor, New Jersey, Aurobindo Pharma USA, Inc. has initiated a voluntary recall of two (2) lots (refer table below) of Quinapril and Hydrochlorothiazide Tablets USP 20mg / 12.5mg, to the consumer level from the US market due to presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N

Vi-Jon, LLC Expands Voluntary Nationwide Recall of Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor Due to Microbial Contamination | FDA

Vi-Jon, LLC Expands Voluntary Nationwide Recall of Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor Due to Microbial Contamination | FDA

Mylan Pharmaceuticals Inc., a Viatris Company, Issues Voluntary Nationwide Recall of One Batch of Insulin Glargine (Insulin glargine-yfgn) Injection Pens, 100 units/mL (U-100), Due to the Potential of Missing Labels on Some Pens | FDA

Mylan Pharmaceuticals Inc., a Viatris Company, Issues Voluntary Nationwide Recall of One Batch of Insulin Glargine (Insulin glargine-yfgn) Injection Pens, 100 units/mL (U-100), Due to the Potential of Missing Labels on Some Pens | FDA : Mylan Pharmaceuticals Inc., a Viatris company, is voluntarily recalling one batch of Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL prefilled pens which are packaged in cartons of five pens to the consumer level. This product is not the branded Semglee® pen but the un

FDA Alert: Vi-Jon, LLC Issues Voluntary Nationwide Recall of CVS Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor Due to Microbial Contamination

FDA Alert: Vi-Jon, LLC Issues Voluntary Nationwide Recall of CVS Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor Due to Microbial Contamination

Green Pharmaceuticals Inc Issues Voluntary Nationwide Recall of SnoreStop NasoSpray Due to Microbial Contamination | FDA

Green Pharmaceuticals Inc Issues Voluntary Nationwide Recall of SnoreStop NasoSpray Due to Microbial Contamination | FDA : SnoreStop NasoSpray

FDA Alert: Teva Issues Voluntary Nationwide Recall of One Lot of Anagrelide Capsules, USP 0.5 mg Due to Dissolution Test Failure

FDA Alert: Teva Issues Voluntary Nationwide Recall of One Lot of Anagrelide Capsules, USP 0.5 mg Due to Dissolution Test Failure

FDA Alert: FDA Alerts Customers to Voluntary Recall of Compounded Drugs Due to Sterility Issues by Drug Depot, LLC, dba APS Pharmacy

FDA Alert: FDA Alerts Customers to Voluntary Recall of Compounded Drugs Due to Sterility Issues by Drug Depot, LLC, dba APS Pharmacy

FDA Alert: Pfizer Voluntary Nationwide Recall of Lots of Accupril (Quinapril HCl) Due to N-Nitroso-Quinapril Content

FDA Alert: Pfizer Voluntary Nationwide Recall of Lots of Accupril (Quinapril HCl) Due to N-Nitroso-Quinapril Content

Mylan Pharmaceuticals Inc., a Viatris Company, Conducting Voluntary Nationwide Recall of One Batch of Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), Due to the Potential for a Missing Label in the Batch | FDA

Mylan Pharmaceuticals Inc., a Viatris Company, Conducting Voluntary Nationwide Recall of One Batch of Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), Due to the Potential for a Missing Label in the Batch | FDA

Pfizer Voluntary Nationwide Recall of Lots of ACCURETIC™ (quinapril HCl/hydrochlorothiazide), quinapril and hydrochlorothiazide Tablets, and quinapril HCl/hydrochlorothiazide Tablets Due to N-Nitroso- Quinapril Content | Pfizer

Pfizer Voluntary Nationwide Recall of Lots of ACCURETIC™ (quinapril HCl/hydrochlorothiazide), quinapril and hydrochlorothiazide Tablets, and quinapril HCl/hydrochlorothiazide Tablets Due to N-Nitroso- Quinapril Content | Pfizer : FOR IMMEDIATE RELEASE - NEW YORK, NY., March 21,2022. Pfizer is voluntarily recalling Accuretic (quinapril HCl/hydrochlorothiazide) tablets distributed by Pfizer as well as two authorized generics distributed by Greenstone (quinapril and hydrochlorothiazide and quinapril HCl/ hydrochlorothiazide) to the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-quinapril, above the Acceptable Daily Intake (ADI) level. Pfizer will recall six lots of Accuretic tablets, one lot of quinapril and hydrochlorothiazide tablets and four lots of quinapril HCl/ hydrochlorothiazide tablets.

Tennessee Technical Coatings Corp Issues Nationwide Voluntary Recall of Hand Sanitizer Isopropyl Alcohol Antiseptic 75% Due to Presence of Methanol | FDA

Tennessee Technical Coatings Corp Issues Nationwide Voluntary Recall of Hand Sanitizer Isopropyl Alcohol Antiseptic 75% Due to Presence of Methanol | FDA : Tennessee Technical Coatings Corp. is voluntarily recalling all lots of HAND SANITIZER Isopropyl Alcohol Antiseptic 75% to the consumer/user level. FDA analysis has found the product to contain methanol.

AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Polymyxin B for Injection USP, 500,000 Unit per Vial, Due to the Presence of Particulate Matter | FDA

AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Polymyxin B for Injection USP, 500,000 Unit per Vial, Due to the Presence of Particulate Matter | FDA

FDA Alert: Blaine Labs Issues Voluntary Nationwide Recall of RevitaDerm Wound Care Gel Due to Bacterial Contamination

FDA Alert: Blaine Labs Issues Voluntary Nationwide Recall of RevitaDerm Wound Care Gel Due to Bacterial Contamination

Mylan Pharmaceuticals Inc., a Viatris Company, Conducting Voluntary Recall of One Batch of Semglee® (insulin glargine injection), 100 units/mL (U-100), 3 mL Prefilled Pens, Due to the Potential for a Missing Label in the Batch | FDA

Mylan Pharmaceuticals Inc., a Viatris Company, Conducting Voluntary Recall of One Batch of Semglee® (insulin glargine injection), 100 units/mL (U-100), 3 mL Prefilled Pens, Due to the Potential for a Missing Label in the Batch | FDA

Viona Pharmaceuticals Inc., Issues Voluntary Nationwide Recall of Metformin HCl Extended- Release Tablets, USP 750 mg, Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity | FDA

Viona Pharmaceuticals Inc., Issues Voluntary Nationwide Recall of Metformin HCl Extended- Release Tablets, USP 750 mg, Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity | FDA

Taro Pharmaceuticals U.S.A. Issues Voluntary Nationwide Recall of Clobetasol Propionate Ointment USP, 0.05%, 60 g Tubes, Lot AC13786 Due to Microbial Contamination | FDA

Taro Pharmaceuticals U.S.A. Issues Voluntary Nationwide Recall of Clobetasol Propionate Ointment USP, 0.05%, 60 g Tubes, Lot AC13786 Due to Microbial Contamination | FDA : Taro Pharmaceuticals U.S.A., Inc. (“Taro” or the “Company”) is voluntarily recalling one (1) lot of Clobetasol Propionate Ointment USP, 0.05% packaged in 60 g tubes, to the consumer level. This recall ONLY applies to tubes labeled with “Lot AC13786” and “Exp Dec 2022”. No other lots of this product

FDA Alert: Taro Pharmaceuticals Issues Voluntary Nationwide Recall of Clobetasol Propionate Ointment USP, 0.05%, 60 g Tubes, Lot AC13786 Due to Microbial Contamination

FDA Alert: Taro Pharmaceuticals Issues Voluntary Nationwide Recall of Clobetasol Propionate Ointment USP, 0.05%, 60 g Tubes, Lot AC13786 Due to Microbial Contamination

FDA Alert: Viona Issues Voluntary Nationwide Recall of Metformin HCl Extended-Release Tablets, USP 750 mg Due to the Detection of NDMA Impurity

FDA Alert: Viona Issues Voluntary Nationwide Recall of Metformin HCl Extended-Release Tablets, USP 750 mg Due to the Detection of NDMA Impurity

FDA Alert: Padagis Issues Voluntary Nationwide Recall for Nitroglycerin Lingual Spray Due to a Possible Defective Delivery System

FDA Alert: Padagis Issues Voluntary Nationwide Recall for Nitroglycerin Lingual Spray Due to a Possible Defective Delivery System