Drug recall D-0578-2023

Class II Ongoing reported May 24, 2023

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

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.

Lots and codes

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

Recall details

Recalling firm
RemedyRepack Inc., Indiana, PA
Quantity
29 x 30-count card, 1 x 100 UD box
Distribution
Product was distrituded to three direct account in PA.
Type
Voluntary: Firm initiated
Recall initiated
May 1, 2023