FDA-Drug2022-10-26Class II

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

Golden State Medical Supply Inc.
Hazard

Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).

Sold states
USA nationwide
Affected count
N/A
Manufactured in
5187 Camino Ruiz, N/A, Camarillo, CA, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0012-2023

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