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Recall Observatory FDA recall evidence

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

D-0012-2023

October 06, 2022

Class II

Product summary

Firm
Golden State Medical Supply Inc.
Event
Event 90992
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
drug-enforcement:D-0012-2023

Official wording

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

Code information: Lot #: GS036715, GS037569, GS038132, GS038665, GS038750, GS039565, GS039997, GS040673, Exp 10/31/2022; GS040674, GS041237, GS041652, GS042152, GS043365, Exp 3/31/2023; GS045441, GS045677, GS046111, Exp 2/29/2024.

Distribution pattern: USA nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Failed impurities/degradation specifications