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.
Reported: February 23, 2022 Initiated: February 15, 2022 #D-0568-2022
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.
Reason for Recall
cGMP Deviations
Details
- Recalling Firm
- ANI Pharmaceuticals, Inc.
- Units Affected
- 5,477 bottles
- Distribution
- Nationwide within the United States
- Location
- Baudette, MN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by ANI Pharmaceuticals, Inc.. Units affected: 5,477 bottles.
Why was this product recalled? ▼
cGMP Deviations
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 23, 2022. Severity: Moderate. Recall number: D-0568-2022.
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