Status
Terminated
Drug Enforcement D-0011-2023
Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
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Classification
Class II
Report Date
October 26, 2022
Termination Date
March 19, 2025
Product Information
- 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.
- Product quantity
- N/A
- Reason for recall
- Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- USA nationwide
Location & Firm
- Recalling firm
- Golden State Medical Supply Inc.
- Address
-
5187 Camino Ruiz, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0011-2023
- Event ID
- 90992
- Recall initiation date
- October 6, 2022
- Center classification date
- October 17, 2022
- Code info
- 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
- More code info
- —