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Recall Observatory FDA recall evidence

Drug product

Pyrazinamide, 500 mg Tablet, packaged in a) 29 x 30-count card, NDC # 70518-2534-01; b) 1 x 100 UD box, NDC # 70518-2534-00, MFG: Akorn, Lake Forest, IL 60045, Repackaged by : RemedyRepack Inc., PA 15701. Mfg NDC # 61748-0012-01

D-0578-2023

May 01, 2023

Class II

Product summary

Firm
RemedyRepack Inc.
Event
Event 92239
Status
Ongoing
Classification
Class II
Quantity
29 x 30-count card, 1 x 100 UD box
Official record key
drug-enforcement:D-0578-2023

Official wording

Reason: CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.

Code information: Lot: a) B2110254-021423, exp. date 08/17/2023; b) J0684183-022323, exp. date 02/28/2024;

Distribution pattern: Product was distrituded to three direct account in PA.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations