Drug product
GSMS: Ranitidine Capsules 300 mg, Rx only, 100 count bottles (NDC 51407-098-01) Manufactured by Novitium Pharma LLC, 70 Lake Drive, East Windsor, New Jersey 08520; Packaged by GSMS, Incorporated, Carmillo, CA 93012 USA.
D-0308-2020
Product summary
- Event
- Event 84233
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0308-2020
Official wording
Reason: CGMP Deviations: Presence of NDMA impurity detected in product.
Code information: Lot Codes: GS023971, Exp. 10/31/2020; GS025527, Exp. 10/31/2020; GS025526, Exp. 10/31/2020; GS026114, Exp. 10/31/2020; GS025813, Exp. 10/31/2020; GS026189, Exp. 10/31/2021; GS027555, Exp. 7/31/2021; GS026190, Exp. 5/31/2021; GS026220, Exp. 05/31/2021; GS026584, Exp. 05/31/2021; GS027139, Exp. 05/31/2021; GS027554, Exp. 05/31/2021.
Distribution pattern: AZ, IA, MA, MO
Derived failure modes
-
Foreign material or chemical contamination
NDMA impurity
-
Manufacturing or process control
CGMP Deviations