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
Product summary
- 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
CGMP Deviations