D-0011-2023 Class II Terminated
FDA drug recall D-0011-2023 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, 300 mg, packaged in a) 30-count bottle (NDC 51407-323-30), b) 60-count bottle (NDC 51407-323-60), c) 100-count bottle (NDC 51407-323-01), Rx only, Manufactured by Patheon Pharmaceuticals Inc., OH, Packaged by GSMS, Incorporated, CA.
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#: a) GS041430, GS041941, Exp 1/31/2023; GS041315, GS042991, GS043027, GS043367, GS043501, GS044421, Exp 3/31/2023; b) GS041431, GS041799, GS042287, GS042414, GS042879, Exp: 1/31/2023; GS041316, GS042992, GS043368, GS043579, Exp 3/31/2023; c) GS041429, GS041877, Exp 1/31/2023; GS041317, GS043028, GS043366, GS044422, Exp 3/31/2023
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0011-2023
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026