Drug recalls
500 recallsPeriGiene, Health Care Antiseptic, Chloroxylenol 0.5%
DermaRite Industries, LLC
CGMP Deviation;
DermaMed Ointment, Skin Protectant, Aluminum Hydroxide Gel 2%
DermaRite Industries, LLC
CGMP Deviation;
PeriGuard Ointment, Petrolatum 49.9%
DermaRite Industries, LLC
CGMP Deviation;
Renew PeriProtect, Zinc Oxide 12%, Dimethicone 1%
DermaRite Industries, LLC
CGMP Deviation;
NIACIN Extended-Release Tablets, USP, 1,000 mg, 90 tablets per bottle
Golden State Medical Supply Inc.
Failed Dissolution Specifications
DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E
DermaRite Industries, LLC
CGMP Deviation;
San-E-Foam, Alcohol 67%, 1000 mL (34 fl. oz.) per cartridge
DermaRite Industries, LLC
CGMP Deviation;
POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL Flexible Container
Otsuka ICU Medical LLC
Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the produc…
UltraSure Anti-Perspirant & Deodorant
DermaRite Industries, LLC
CGMP Deviation;
GelRite Instant Hand Sanitizer, Alcohol 65%
DermaRite Industries, LLC
CGMP Deviation;
Hand-E-Foam, Benzethonium Chloride 0.20%
DermaRite Industries, LLC
CGMP Deviation;
Renew Skin Repair Cream, Dimethicone 1.5%
DermaRite Industries, LLC
CGMP Deviation;
Lantiseptic, Dry Skin Therapy, Lanolin USP 30%
DermaRite Industries, LLC
CGMP Deviation;
Bromocriptine Mesylate Capsules, USP, 5 mg, 30 Capsules per bottle
Zydus Pharmaceuticals (USA) Inc
Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- B…
McKesson Skin Protectant, Lanolin USP
DermaRite Industries, LLC
CGMP Deviation;
Klarity-C Drops (Cyclosporine) 0.1%
Imprimis NJOF, LLC
Subpotent Drug
4-N-1 Skin Protectant, No Rinse Wash Cream with Dimethicone 1%, 113g
DermaRite Industries, LLC
CGMP Deviation;
Fesoterodine Fumarate, Extended-release Tablets, 4 mg
Alembic Pharmaceuticals Limited
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the s…
DermaCerin, Skin Protectant Moisturizing Cream (petrolatum 33%)
DermaRite Industries, LLC
CGMP Deviation;
clomiPRAMINE Hydrochloride, Capsules, USP, 75 mg
Zydus Pharmaceuticals (USA) Inc
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impuritie…
clomiPRAMINE Hydrochloride, Capsules, USP, 50 mg
Zydus Pharmaceuticals (USA) Inc
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impuritie…
clomiPRAMINE Hydrochloride, Capsules, USP, 25 mg
Zydus Pharmaceuticals (USA) Inc
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impuritie…
Amoxicillin and Clavulanate Potassium for Oral Suspension USP
Teva Pharmaceuticals USA, Inc
Subpotent drug;
Acetaminophen 500mg Caffeine 65mg caplets
Aero Healthcare
Labeling: Label Mix-up.
Semaglutide Injection, 10 mg/4 mL (2.5 mg/mL), 4mL Multidose Vial
ProRx LLC
Lack of Assurance of Sterility
Testosterone / Triamcinolone Acetonide Pellet (100MG/20MCG)
FARMAKEIO OUTSOURCING LLC
CGMP Deviations: Potential presence of metal particulate matter
Desipramine Hydrochloride Tablets, USP, 150 mg
Heritage Pharmaceuticals Inc
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake…
TYLENOL, Acetaminophen, Extra Strength, 24 Caplets, 500mg each
Kenvue Brands LLC
Defective Container
Prazosin Hydrochloride, Capsules, USP, 5 mg
Amerisource Health Services LLC
Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the…
Prazosin Hydrochloride, Capsules, USP, 1 mg, Rx only
Teva Pharmaceuticals USA, Inc
CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Po…