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
Reported: May 24, 2023 Initiated: May 1, 2023 #D-0578-2023
Product Description
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.
Details
- Recalling Firm
- RemedyRepack Inc.
- Units Affected
- 29 x 30-count card, 1 x 100 UD box
- Distribution
- Product was distrituded to three direct account in PA.
- Location
- Indiana, PA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by RemedyRepack Inc.. Units affected: 29 x 30-count card, 1 x 100 UD box.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 24, 2023. Severity: Moderate. Recall number: D-0578-2023.
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