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
Reported: October 26, 2022 Initiated: October 6, 2022 #D-0012-2023
Product Description
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).
Details
- Recalling Firm
- Golden State Medical Supply Inc.
- Units Affected
- N/A
- Distribution
- USA nationwide
- Location
- Camarillo, CA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Golden State Medical Supply Inc.. Units affected: N/A.
Why was this product recalled? ▼
Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 26, 2022. Severity: Moderate. Recall number: D-0012-2023.
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