December 22, 2021DrugsFDA
Teligent Pharma, Inc. recalls Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only, Teligent Pharma Inc., Buena, N
Hazard: CGMP Deviations: Lots recalled because they were manufactured at the same facility using the same components as the products that had cracked seals in caps that were found to be superpotent.
December 22, 2021DrugsFDA
Teligent Pharma, Inc. recalls Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only, Teligent Pharma Inc., Buena, N
Hazard: Superpotent Drug
December 22, 2021DrugsFDA
Teligent Pharma, Inc. recalls Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only, Manufactured by: Teligent Phar
Hazard: CGMP Deviations: Lots recalled because they were manufactured at the same facility using the same components as the products that had cracked seals in caps that were found to be superpotent.
December 22, 2021DrugsFDA
Preferred Pharmaceuticals, Inc. recalls Diclofenac Sodium Topical Solution, 1.5% w/w, packaged in 150 mL bottles, Rx only, Mfg: SOLA Pharmaceuticals Preferred P
Hazard: Defective container: Out of specification for container integrity leading to bottles leaking.
December 15, 2021DrugsFDA
Apollo Care recalls VANComycin 1g added to 250mL of 0.9% Sodium Chloride (Injection for Intravenous Use Only), 260 mL per bag, Rx Only, This
Hazard: Crystallization: Product appears to be turbid.
December 15, 2021DrugsFDA
Ascent Pharmaceuticals, Inc. recalls Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg, 100-count bottle, Rx only, Manufactured for: Camber
Hazard: Product Mix-up
December 15, 2021DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Fexofenadine HCl, 60 mg & Pseudoephedrine HCl 120 mg, Extended Release Tablets USP, Allergy and Congestion, 30 Tablets,
Hazard: Failed dissolution specifications
December 15, 2021DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Allergy Relief D Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg, Extended Release Tablets, USP, 30 Extended-Rele
Hazard: Failed dissolution specifications
December 15, 2021DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Allergy Relief D Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg, Extended Release Tablets, 30 Extended-Release T
Hazard: Failed dissolution specifications
December 15, 2021DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls 12 HR Allergy & Congestion Relief Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg Antihistamine I Nasal Decongesta
Hazard: Failed dissolution specifications
December 15, 2021DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg, Extended Release Tablets USP,
Hazard: Failed dissolution specifications
December 15, 2021DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg, Extended Release Tablets USP,
Hazard: Failed dissolution specifications
December 15, 2021DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg Extended Release Tablets USP Allergy & Congestion, 20 Tablets, Distri
Hazard: Failed dissolution specifications
December 15, 2021DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Allergy & Congestion Relief Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg Extended Release Tablet
Hazard: Failed dissolution specifications
December 15, 2021DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Allergy & Congestion Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg Extended-Release Tablets, USP, 20 Extended-Rele
Hazard: Failed dissolution specifications
December 15, 2021DrugsFDA
American Screening LLC recalls AmericanScreening HAND SANITIZER (ethyl alcohol 70%) ANTIMICROBIAL FORMULA Vitamin E & Moisturizer, 8 FL OZ (237 mL) bot
Hazard: Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles.
December 8, 2021DrugsFDA
Sandoz Inc recalls Enoxaparin Sodium Injection, USP, 40 mg/0.4 mL, Single-Dose Syringes with Automatic Safety Device, For Subcutaneous Inje
Hazard: Temperature Abuse; temperature excursion during shipping
December 8, 2021DrugsFDA
Pfizer Inc. recalls 5% Dextrose Injection, USP, 50 mL ADD-Vantage Unit, Rx only, Distributed by Hospira, INC., Lake Forest, IL 60045 USA, ND
Hazard: Lack of sterility assurance: bag has the potential to leak.
December 8, 2021DrugsFDA
Lupin Pharmaceuticals Inc. recalls Tydemy (drospirenone, ethinyl estradiol & levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium t
Hazard: Subpotent Drug
December 8, 2021DrugsFDA
ASP CARES recalls Ascorbic Acid Solution for Injection, 500 mg/mL, 50 mL Multiple Dose Vial, For IM, IV or SC Use Only, Rx only, ASP Care
Hazard: Lack of Assurance of Sterility
December 8, 2021DrugsFDA
ASP CARES recalls Biotin Solution for Injection, 10 mg/mL, 30 mL Multiple Dose Vial, Sterile, For IM or IV use only, Rx only ASP Cares, 2
Hazard: Lack of Assurance of Sterility
December 8, 2021DrugsFDA
ASP CARES recalls Methylcobalamin Solution for Injection, 1 mg/mL, 30 mL Multiple Dose Vial, For IM, SC or IV Use Only, Rx only, ASP Cares
Hazard: Lack of Assurance of Sterility
December 1, 2021DrugsFDA
Aurobindo Pharma USA Inc. recalls Carvedilol Tablets, USP, 6.25 mg, 500 Tablets bottle, Rx Only, Distributed by: Aurobindo Pharma USA Inc., 279 Princeton-
Hazard: Failed Impurities/Degradation Specifications
December 1, 2021DrugsFDA
Teligent Pharma, Inc. recalls Diclofenac Sodium Topical Solution USP, 1.5 w/w, 5 fl oz (150 mL) plastic bottles, Rx only, Teligent Pharma, Inc., Buena
Hazard: Defective Container
December 1, 2021DrugsFDA
Teligent Pharma, Inc. recalls Diclofenac Sodium Topical Solution USP, 1.5 w/w, 5 fl oz (150 mL) plastic bottles, Rx only, Teligent Pharma, Inc., Buena
Hazard: Defective Container
December 1, 2021DrugsFDA
Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals recalls Butalbital, APAP, Caf 50/325/40 Tablet, packaged in a) 12-count bottles, NDC: 71335-1767-09, barcode 083929164865; b) 20
Hazard: Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on the label
December 1, 2021DrugsFDA
Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals recalls Butalbital, APAP, Caf 50/325/40 Tablets, packaged in a) 12-count bottles, NDC: 63629-8392-09, barcode 083929152151; b) 6
Hazard: Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on the label
December 1, 2021DrugsFDA
UNICHEM PHARMACEUTICALS USA INC recalls Topiramate Tablets, USP 50 mg, 500-count bottles, Rx Only, Manufactured by: Unichem Laboratories LTD, Ind. Area. Meerut
Hazard: Discoloration
November 24, 2021DrugsFDA
Bayer Healthcare Pharmaceuticals Inc. recalls LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray, NET WT 160g (5.6 OZ) can, UPC 0 41100 58720 6, NDC
Hazard: cGMP Deviations: LOTRIMIN AF (Tolnaftate 1%) manufactured at the same facility where other lots were found to be contaminated with benzene.
November 24, 2021DrugsFDA
Bayer Healthcare Pharmaceuticals Inc. recalls Tinactin (Tolnaftate 1%) POWDER SPRAY NET WT 133g (4.6 oz) can, labeled as (a) Product of Ireland 86940418; (b)Product
Hazard: Chemical Contamination: presence of benzene