FDA Drug recall D-0012-2023
Rifampin Capsules, USP, 150 mg, 30-count bottle, Rx only, Manufactured by Patheon Pharmaceuticals Inc., OH, Packaged by GSMS, Incorporated,…
- FDA Drug
- Class II
- terminated
- Published 2022-10-26
On 2022-10-26 the FDA classified a Class II recall of Rifampin Capsules, USP, 150 mg, 30-count bottle, Rx only, Manufactured by Patheon Pharmaceuticals Inc., OH, Packaged by GSMS, Incorporated,… by Golden State Medical Supply, citing failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0012-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-10-06 |
| Published | 2022-10-26 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Golden State Medical Supply |
| Distribution | US |
Product
Rifampin Capsules, USP, 150 mg, 30-count bottle, Rx only, Manufactured by Patheon Pharmaceuticals Inc., OH, Packaged by GSMS, Incorporated, CA, NDC 51407-322-30
Reason
Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
Identifiers
| code_info | Lot #: GS036715, GS037569, GS038132, GS038665, GS038750, GS039565, GS039997, GS040673, Exp 10/31/2022; GS040674, GS0412…Lot #: GS036715, GS037569, GS038132, GS038665, GS038750, GS039565, GS039997, GS040673, Exp 10/31/2022; GS040674, GS041237, GS041652, GS042152, GS043365, Exp 3/31/2023; GS045441, GS045677, GS046111, Exp 2/29/2024. |
|---|
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-0012-2023%22
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