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 Number: D-0011-2023

Firm: Golden State Medical Supply Inc.

Classification: Class II

Status: Terminated

Report Date: 20221026

Initiation Date: 20221006

Termination Date: 20250319

Reason for Recall

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

Product Description

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.