FDAOctober 6, 2022drug

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 recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

golden state medical supplygoldengolden state

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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. — Recall Details · AllClear