Class II
Terminated
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
- Company
- Remedyrepack Inc.
- Recall Initiated
- May 1, 2023
- Posted
- May 24, 2023
- Recall Number
- D-0578-2023
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 29 x 30-count card, 1 x 100 UD box
- Firm Location
- Indiana, PA, United States
Reason for Recall
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.
Distribution
Product was distrituded to three direct account in PA.
Lot / Code Info
Lot: a) B2110254-021423, exp. date 08/17/2023; b) J0684183-022323, exp. date 02/28/2024;
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