GSMS: Ranitidine Capsules 300 mg — Class II drug recall D-0308-2020
Terminated recall by Golden State Medical Supply Inc., reported 2019-11-20, distributed in AZ, IA, MA, MO. CGMP Deviations: Presence of NDMA impurity detected in product.
| Recall number | D-0308-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Golden State Medical Supply Inc., Camarillo, CA, United States |
| Recall initiated | 2019-11-06 |
| Classified | 2019-11-10 |
| Reported by FDA | 2019-11-20 |
| Terminated | 2021-04-15 |
| Distributed | AZ, IA, MA, MO |
| Reason classes | chemical contamination, cgmp, specification failure |
| NDC | 51407-0098-01 |
| Lot numbers | GS023971, GS025526, GS025527, GS025813, GS026114, GS026189, GS026190, GS026220, GS026584, GS027139, GS027554, GS027555 |
| Expiration dates | 2020-10-31, 2021-05-31, 2021-07-31, 2021-10-31 |
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.
Reason for recall
CGMP Deviations: Presence of NDMA impurity detected in product.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0308-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.