Drug product
AVKARE Ranitidine Hydrochloride Capsules 150 mg 500 Capsules Rx Only NDC 42291-735-50 UPC 342291735507 Manufactured for: AvKARE, Inc. Pulaski, TN 38478
D-0164-2020
Product summary
- Firm
- AVKARE Inc.
- Event
- Event 84081
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7293 bottles
- Official record key
drug-enforcement:D-0164-2020
Official wording
Reason: CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Code information: Lot 17708 Exp.11/30/2019 Lot 18459 Exp.03/31/2020 Lot 19033 Exp.07/31/2020 Lot 19032 Exp.07/31/2020 Lot 19031 Exp.06/30/2020 Lot 20204 Exp.09/30/2020 Lot 20205 Exp.09/30/2020 Lot 20663 Exp.10/31/2020 Lot 20664 Exp.11/30/2020 Lot 20665 Exp.11/30/2020 Lot 20666 Exp.11/30/2020 Lot 21039 Exp.12/31/2020 Lot 21920 Exp.04/30/2021
Distribution pattern: CO, MO
Derived failure modes
-
Foreign material or chemical contamination
Impurity N-nitrosodimethylamine (NDMA
-
Manufacturing or process control
CGMP Deviations