FDA Drug recall D-0307-2020
GSMS: Ranitidine Capsules 150 mg, Rx only, 500 count bottles (NDC 51407-097-05) Manufactured by Novitium Pharma LLC, 70 Lake Drive, East Wi…
- FDA Drug
- Class II
- terminated
- Published 2019-11-20
On 2019-11-20 the FDA classified a Class II recall of GSMS: Ranitidine Capsules 150 mg, Rx only, 500 count bottles (NDC 51407-097-05) Manufactured by Novitium Pharma LLC, 70 Lake Drive, East Wi… by Golden State Medical Supply, citing CGMP Deviations: Presence of NDMA impurity detected in product.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0307-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-11-06 |
| Published | 2019-11-20 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Golden State Medical Supply |
| Distribution | AZ, IA, MA, MO |
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
CGMP Deviations: Presence of NDMA impurity detected in product.
Identifiers
| code_info | Lot Codes: GS023970, Exp. 10/31/2020; GS026108, Exp. 10/31/2020;GS026099, Exp. 10/31/2020; GS026838, Exp. 10/31/2020; G…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0307-2020%22
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