D-0012-2023 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- October 26, 2022
- Initiation Date
- October 6, 2022
- Termination Date
- March 19, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
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.