Why it was recalled
cGMP Deviations
Product description
Pyrazinamide Tablets, USP 500 mg, 100-count bottles, Rx only, Manufactured by: ULTRAtab Laboratories, Inc. Highland, NY 12528, Distributed by Par Pharmaceuticals, Chestnut Ridge, NY 10977, NDC 67253-660-10.
Lot numbers, UPCs & expiration codes
Lot #: 19B064A, Exp. Date 03/2022
Where it was sold
Nationwide within the United States
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-0568-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 15, 2022
- FDA report date
- Feb 23, 2022
- Quantity
- 5,477 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- ANI Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0568-2022, exactly as published.
Show all FDA fields
- City
- Baudette
- State
- MN
- Status
- Terminated
- Country
- United States
- Event ID
- 89556
- Address
- 210 W Main St
- Code information
- Lot #: 19B064A, Exp. Date 03/2022
- Postal code
- 56623-2467
- Report date
- Feb 23, 2022
- Product type
- Drugs
- Recall number
- D-0568-2022
- Classification
- Class II
- Recalling firm
- ANI Pharmaceuticals, Inc.
- Product quantity
- 5,477 bottles
- Termination date
- Oct 25, 2022
- Reason for recall
- cGMP Deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Pyrazinamide Tablets, USP 500 mg, 100-count bottles, Rx only, Manufactured by: ULTRAtab Laboratories, Inc. Highland, NY 12528, Distributed by Par Pharmaceuticals, Chestnut Ridge, NY 10977, NDC 67253-660-10.
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Feb 15, 2022
- Initial firm notification
- Letter
- Center classification date
- Feb 17, 2022