Why it was 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.
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
Lot numbers, UPCs & expiration codes
Lot: a) B2110254-021423, exp. date 08/17/2023; b) J0684183-022323, exp. date 02/28/2024;
Where it was sold
Product was distrituded to three direct account in PA.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0578-2023
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- May 1, 2023
- FDA report date
- May 24, 2023
- Quantity
- 29 x 30-count card, 1 x 100 UD box
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- RemedyRepack Inc.
Original FDA data
Every field from FDA enforcement report D-0578-2023, exactly as published.
Show all FDA fields
- City
- Indiana
- State
- PA
- Status
- Ongoing
- Country
- United States
- Event ID
- 92239
- Address
- 625 Kolter Dr Ste 4
- Code information
- Lot: a) B2110254-021423, exp. date 08/17/2023; b) J0684183-022323, exp. date 02/28/2024;
- Postal code
- 15701-3571
- Report date
- May 24, 2023
- Product type
- Drugs
- Recall number
- D-0578-2023
- Classification
- Class II
- Recalling firm
- RemedyRepack Inc.
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Product was distrituded to three direct account in PA.
- Recall initiation date
- May 1, 2023
- Initial firm notification
- Letter
- Center classification date
- May 16, 2023