Drug Enforcement D-0012-2023

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

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Status

Terminated

Classification

Class II

Report Date

October 26, 2022

Termination Date

March 19, 2025

Product Information

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
Product quantity
N/A
Reason for recall
Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
USA nationwide

Location & Firm

Recalling firm
Golden State Medical Supply Inc.
Address
5187 Camino Ruiz, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0012-2023
Event ID
90992
Recall initiation date
October 6, 2022
Center classification date
October 17, 2022
Code info
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.
More code info
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