Drug product
AVKARE Ranitidine Hydrochloride Capsules 300 mg 500 Capsules Rx Only NDC 42291-736-50 UPC 342291736504 Manufactured for: AvKARE, Inc. Pulaski, TN 38478
D-0165-2020
Product summary
- Firm
- AVKARE Inc.
- Event
- Event 84081
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1351 bottles
- Official record key
drug-enforcement:D-0165-2020
Official wording
Reason: CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Code information: Lot 17709 Exp.01/31/2020 Lot 18460 Exp.02/29/2020 Lot 19853 Exp.09/30/2020 Lot 22362 Exp.11/30/2020 Lot 22579 Exp.11/30/2020
Distribution pattern: CO, MO
Derived failure modes
-
Foreign material or chemical contamination
Impurity N-nitrosodimethylamine (NDMA
-
Manufacturing or process control
CGMP Deviations