FDAFDA · Food and drugs·Recall number D-0012-2023
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
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 #: 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.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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