Status
Ongoing
Drug Enforcement D-0578-2023
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.
Classification
Class II
Report Date
May 24, 2023
Termination Date
—
Product Information
- 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
- Product quantity
- 29 x 30-count card, 1 x 100 UD box
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Product was distrituded to three direct account in PA.
Location & Firm
- Recalling firm
- RemedyRepack Inc.
- Address
-
625 Kolter Dr Ste 4
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0578-2023
- Event ID
- 92239
- Recall initiation date
- May 1, 2023
- Center classification date
- May 16, 2023
- Code info
- Lot: a) B2110254-021423, exp. date 08/17/2023; b) J0684183-022323, exp. date 02/28/2024;
- More code info
- —