💊 Drugs Class I - Dangerous
Subpotency: one product for active ingredient assay and another one for preservative assay
All Recalls
95,025 total recalls in our database
💊 Drugs Class I - Dangerous
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Naproxen Sodium Tablets, USP 275 mg 100 Tablets Rx Only NDC 68462-178-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430
Glenmark Pharmaceuticals Inc., USA
💊 Drugs Class I - Dangerous
CGMP Deviations
Zonisamide Capsules USP 100 mg Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 a) 100 Capsules NDC 68462-130-01; b) 500 Capsules NDC 68462-130-05
Glenmark Pharmaceuticals Inc., USA
💊 Drugs Class I - Dangerous
CGMP Deviations
💊 Drugs Class I - Dangerous
Subpotent Drug
Chlorzoxazone Tablets USP 375 mg 100 Tablets Rx Only NDC 68462-724-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430
Glenmark Pharmaceuticals Inc., USA
💊 Drugs Class I - Dangerous
CGMP Deviations
💊 Drugs Class I - Dangerous
Subpotency: one product for active ingredient assay and another one for preservative assay
💊 Drugs Class I - Dangerous
CGMP deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
Avicel RC-591 NF (MCC/Carboxymethylcellulose Sodium) NF, bulk powder, 80.0 KG drum, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711
DuPont Nutrition USA
💊 Drugs Class I - Dangerous
Microbial Contamination of Non-Sterile Product: Out-of-specification results obtained for total aerobic microbial count (TAMC).
💊 Drugs Class I - Dangerous
Marketed without an approved NDA/ANDA: Product found to be tainted with Tadalafil.
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility
💊 Drugs Class I - Dangerous
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
💊 Drugs Class I - Dangerous
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Promethazine Syrup Plain, 6.25 mg/5 mL (Promethazine Hydrochloride Syrup, USP), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054; Manuractured By: Morton Grove Pharmaceuticals, Inc, Morton Grove, IL 60053. NDC: 60432-608-16
Morton Grove Pharmaceuticals
💊 Drugs Class I - Dangerous
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
DLP Left Heart Vent Catheters, 18 FR. Sterile, Rx Only
Medtronic Perfusion Systems
🏥 Medical Devices Class I - Dangerous
Potential for a wire protrusion through the left heart vent catheter tip
🏥 Medical Devices Class I - Dangerous
There is potential for packaging defects that may impact the sterile barrier.
🏥 Medical Devices Class I - Dangerous
There is potential for packaging defects that may impact the sterile barrier.
🏥 Medical Devices Class I - Dangerous
Image acquisition failures and synchronization failure with the Centricity Enterprise Archive
Catalog A899916, SureStep" Foley Tray, Lubricath", Drainage Bag, StatLock" Stabilization Device
C.R. Bard
🏥 Medical Devices Class I - Dangerous
There is potential for packaging defects that may impact the sterile barrier.
🏥 Medical Devices Class I - Dangerous
Malfunction- loosening of the implant resulting in a potential revision surgery