FDA recall D-0012-2023

Golden State Medical Supply Inc. · Class II · drug

Product

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

Reason for recall

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

Distribution

USA nationwide

Key facts

Status: Terminated
Initiation date: 2022-10-06
Report date: 2022-10-26
Termination date: 2025-03-19
Voluntary/Mandated: Voluntary: Firm initiated
Location: Camarillo, CA, United States

Primary source

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