Recalls / Class II
Class IID-0568-2022
Product
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.
- Affected lot / code info
- Lot #: 19B064A, Exp. Date 03/2022
Why it was recalled
cGMP Deviations
Recalling firm
- Firm
- ANI Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 210 W Main St, N/A, Baudette, Minnesota 56623-2467
Distribution
- Quantity
- 5,477 bottles
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2022-02-15
- FDA classified
- 2022-02-17
- Posted by FDA
- 2022-02-23
- Terminated
- 2022-10-25
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0568-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.