FDAFDA · Food and drugs·Recall number D-0011-2023
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.
Published October 26, 2022 · Recall initiated: October 6, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Golden State Medical Supply Inc.
- Distributor
- USA nationwide
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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