GSMS: Ranitidine Capsules 150 mg, Rx only, 500 count bottles (NDC 51407-097-05) Manufactured by Novitium Pharma LLC, 70 Lake Drive, East Windsor, New Jersey 08520; Packaged by GSMS, Incorporated, Carmillo, CA 93012 USA.
FDA recall notice · announced November 20, 2019 · Golden State Medical Supply
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The product
GSMS: Ranitidine Capsules 150 mg, Rx only, 500 count bottles (NDC 51407-097-05) Manufactured by Novitium Pharma LLC, 70 Lake Drive, East Windsor, New Jersey 08520; Packaged by GSMS, Incorporated, Carmillo, CA 93012 USA.
Reason for recall
CGMP Deviations: Presence of NDMA impurity detected in product.
Notes
Distribution: AZ, IA, MA, MO
Lot/code information: Lot Codes: GS023970, Exp. 10/31/2020; GS026108, Exp. 10/31/2020;GS026099, Exp. 10/31/2020; GS026838, Exp. 10/31/2020; GS025702, Exp. 10/31/2020; GS027272, Exp. 10/31/2020; GS027273, Exp. 05/31/2021.
Quantity: N/A
Status: Terminated
Products in this recall event:
- 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, Carm (D-0308-2020)
- GSMS: Ranitidine Capsules 150 mg, Rx only, 500 count bottles (NDC 51407-097-05) Manufactured by Novitium Pharma LLC, 70 Lake Drive, East Windsor, New Jersey 08520; Packaged by GSMS, Incorporated, Carm (D-0307-2020)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.