FDA-Drug2023-05-24Class II
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
RemedyRepack Inc.
Hazard
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.
Sold states
Product was distrituded to three direct account in PA.
Affected count
29 x 30-count card, 1 x 100 UD box
Manufactured in
625 Kolter Dr Ste 4, Indiana, PA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0578-2023Don't want to check this manually?
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