D-0012-2023 Class II Terminated
FDA drug recall D-0012-2023 was initiated by Golden State Medical Supply Inc. on Oct 6, 2022 and is designated Class II. Reason for recall: Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP). The recall status is terminated (terminated Mar 19, 2025).
Recall details
- Product Type
- Drugs
- Report Date
- Oct 26, 2022
- Initiation Date
- Oct 6, 2022
- Termination Date
- Mar 19, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
Product description
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 for recall
Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
Distribution pattern
USA nationwide
Code information
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.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0012-2023
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026