FDA-Drug2022-10-26Class II
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.
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, 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0011-2023Don't want to check this manually?
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