ANI Pharmaceuticals, Inc.: Drug Recall

Recall #D-0568-2022 · 02/15/2022

Class II: Risk

Recall Details

Recall Number
D-0568-2022
Classification
Class II
Product Type
Drug
Recalling Firm
ANI Pharmaceuticals, Inc.
Status
Terminated
Date Initiated
02/15/2022
Location
Baudette, MN, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5,477 bottles

Reason for Recall

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.

Distribution Pattern

Nationwide within the United States

Other Recalls by ANI Pharmaceuticals, Inc.

View all recalls by ANI Pharmaceuticals, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.