Drug product
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.
D-0011-2023
Product summary
- Event
- Event 90992
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0011-2023
Official wording
Reason: Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
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
Distribution pattern: USA nationwide
Derived failure modes
-
Potency or specification failure
Failed impurities/degradation specifications