April 6, 2022DrugsFDA
Drug Depot, Inc., dba APS Pharmacy recalls (CA) GONADORELIN (4ML) 0.2 MG/ML INJECTABLE, Packaged in a multi dose 10ML vial, Formula ID136345, APS Pharmacy
Hazard: Lack of sterility assurance.
April 6, 2022DrugsFDA
Drug Depot, Inc., dba APS Pharmacy recalls GONADORELIN (5ML) 0.2 MG/ML INJECTABLE, Packaged in a multi dose 10ML vial, Formula ID132227, APS Pharmacy
Hazard: Lack of sterility assurance.
April 6, 2022DrugsFDA
Taro Pharmaceuticals U.S.A., Inc. recalls Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%,15 g tubes, Rx only, Manufactured by: Taro Pharmaceutica
Hazard: Failed Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipropionate assay of a stability sample
April 6, 2022DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Atorvstatin Calcium Tablets, USP 80 mg*, 90 Tablets, Rx Only, Mrd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 53
Hazard: Failed Impurities/Degradation Specifications: Out of Specification results for related substance.
March 30, 2022DrugsFDA
Fresenius Kabi USA, LLC recalls Sodium Acetate Injection, USP, 400 mEq / 100 mL (4 mEq / mL), packaged in 2 trays of 20 vials per shipper (NDC 63323-032
Hazard: Presence of particulate matter: particulates composed of carbon and oxygen with varying amounts of iron and trace amounts of sodium, silicon, chromium, aluminum and cellulose.
March 30, 2022DrugsFDA
Tennessee Technical Coatings, Corp. recalls HAND SANITIZER Isopropyl Alcohol Antiseptic 75%, Net contents: 1 U.S. Gallon/3.785 Liters Tennessee Technical Coatings
Hazard: CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.
March 30, 2022DrugsFDA
Tennessee Technical Coatings, Corp. recalls HAND SANITIZER Isopropyl Alcohol Antiseptic 75%, Net contents: 1 U.S. Gallon/3.785 Liters Tennessee Technical Coatings
Hazard: Chemical Contamination: FDA analysis found 1 lot of HAND SANITIZER Isopropyl Alcohol Antiseptic 75%, to contain methanol.
March 30, 2022DrugsFDA
Olympia Compounding Pharmacy dba Olympia Pharmacy recalls Sincalide Lyophilized powder for reconstitution Each ML contains: Mannitol 170mg, Arginine 30mg, Lysine 15mg, Potassium
Hazard: Super Potent and Failed Reconstitution Time
March 30, 2022DrugsFDA
Olympia Compounding Pharmacy dba Olympia Pharmacy recalls Hydroxocobalamin B12 1mg/mL, Multi-Dose 30 mL vial, Each ML contains: 0.82% Sodium Chloride USP, 0.9% Benzyl Alcohol NF,
Hazard: Sub Potent
March 30, 2022DrugsFDA
Olympia Compounding Pharmacy dba Olympia Pharmacy recalls SB-4, Papaverine 30mg/mL, Phentolamine 3mg/mL, Alprostadil 40mcg/mL, packaged in a) 5 mL Multi-dose vial NDC 73198-0023-
Hazard: Sub Potent
March 30, 2022DrugsFDA
Olympia Compounding Pharmacy dba Olympia Pharmacy recalls T-105, Papaverine 30 mg/mL Phentolamine 1 mg/mL PGE 10 mcg/mL packaged as a) 5 mL Multi-dose NDC 73198-0005-05; b) 10 mL
Hazard: Super Potent
March 30, 2022DrugsFDA
Olympia Compounding Pharmacy dba Olympia Pharmacy recalls Formula F9, Papaverine 0.9 mg/mL, Phentolamine 0.1 mg/mL, PGE 20 mcg/mL, Atropine 0.01 mg/mL, Multi-Dose 10 mL vial, Eac
Hazard: Sub Potent
March 30, 2022DrugsFDA
Olympia Compounding Pharmacy dba Olympia Pharmacy recalls NAD+ Nicotinamide Adenine Dinucleotide, Lyophilized powder for reconstitution, Multi-Dose 500 mg per vial, Each ML conta
Hazard: Product found to be Sub Potent or Exceeded reconstitution time
March 30, 2022DrugsFDA
Olympia Compounding Pharmacy dba Olympia Pharmacy recalls Sermorelin Acetate Lyophilized powder for reconstitution, Multi-Dose 9 mg per vial, Each ML contains: 5% Mannitol USP, S
Hazard: Sub Potent
March 30, 2022DrugsFDA
Akorn, Inc. recalls TheraTears Extra (sodium carboxymethylcellulose) 0.25% Lubricant Eye Drops, 30 Sterile Single-Use Vials per box, Akorn C
Hazard: Lack of Assurance of Sterility
March 30, 2022DrugsFDA
Rock Town Distillery, Inc. recalls ROCK TOWN - DISTILLERY - HAND SANITIZER, Alcohol Antiseptic 70%, Topical Solution packaged in a) 375 mL (12.7 fl. oz.),
Hazard: CGMP Deviations: FDA analysis found product to contain acetal and acetaldehyde above specification limits.
March 30, 2022DrugsFDA
Direct Rx recalls Diclofenac Sodium Topical Solution 1.5%, 150 mL, Rx only, Packaged and Distributed by: Direct Rx Dawsonville, GA 30534 M
Hazard: Defective Container: Leaking containers.
March 30, 2022DrugsFDA
Athenex Pharma Solutions, LLC recalls Epinephrine Injection 8 mg per 250 mL in 0.9% Sodium Chloride, 8mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions,
Hazard: Defective container
March 30, 2022DrugsFDA
Athenex Pharma Solutions, LLC recalls Phenylephrine HCl Injection in 0.9% Sodium Chloride, 20 mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Cl
Hazard: Defective container
March 30, 2022DrugsFDA
Athenex Pharma Solutions, LLC recalls Phenylephrine HCl Injection 50 mg per 250 mL in 0.9% Sodium Chloride, 50 mg, 250 mL excel bag, Rx only, Athenex Pharma S
Hazard: Defective container
March 30, 2022DrugsFDA
Athenex Pharma Solutions, LLC recalls Phenylephrine HCl Injection 40 mg per 250 mL in 0.9% Sodium Chloride, 40 mg, 250 mL excel bag, Rx only, Athenex Pharma S
Hazard: Defective container
March 30, 2022DrugsFDA
Athenex Pharma Solutions, LLC recalls Norepinephrine Bitartrate Injection 8 mg per 250 mL in 0.9% Sodium Chloride, 8 mg, 250 mL excel bag, Rx only, Athenex Ph
Hazard: Defective container
March 30, 2022DrugsFDA
Athenex Pharma Solutions, LLC recalls Norepinephrine Bitartrate Injection 16 mg per 250 mL added to 0.9% Sodium Chloride, 16 mg, 250 mL excel bag, Rx only, At
Hazard: Defective container
March 30, 2022DrugsFDA
Athenex Pharma Solutions, LLC recalls Norepinephrine Bitartrate Injection 4mg per 250 mL in 0.9% Sodium Chloride, 4 mg, 250 mL excel bag, Rx only, Athenex Pha
Hazard: Defective container
March 30, 2022DrugsFDA
Teligent Pharma, Inc. recalls Lidocaine Ointment USP, 5%, Net Wt 35.44 g (1 1/4 Oz) tube, Rx Only, Manufactured for: Hi-Tech Pharmacal Co., Inc., Amit
Hazard: cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
March 30, 2022DrugsFDA
Teligent Pharma, Inc. recalls Lidocaine Cream 4%, Net Wt. 30 grams tube, Distributed by: RUGBY LABORATORIES, 17177 N. Laurel Park Dr., Suite 233, Livo
Hazard: cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
March 30, 2022DrugsFDA
Teligent Pharma, Inc. recalls Hydrocortisone Butyrate Lotion, 0.1%, 4 fl oz (118 mL) bottle, Rx only, Manufactured for: SOLA Pharmaceuticals, Baton Ro
Hazard: cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
March 30, 2022DrugsFDA
Teligent Pharma, Inc. recalls Gentamicin Sulfate Cream USP, 0.1%, packaged in 30 grams tubes, Rx Only, Manufactured for: SOLA Pharmaceuticals, LLC, Ba
Hazard: cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
March 30, 2022DrugsFDA
Teligent Pharma, Inc. recalls Diflorasone Diacetate Ointment USP, 0.05%, Net Wt 60 g tubes, Rx only, Manufactured by: Teligent Pharm, Inc., Buena, New
Hazard: cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
March 30, 2022DrugsFDA
Teligent Pharma, Inc. recalls Clobetasol Propionate Cream USP, 0.05%, packaged in 60 grams tube, Rx only, Manufactured for SOLA Pharmaceuticals, Baton
Hazard: cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.