Drug recall D-0568-2022

Class II Terminated reported Feb 23, 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.

Reason for recall

cGMP Deviations

Lots and codes

Lot #: 19B064A, Exp. Date 03/2022

Recall details

Recalling firm
ANI Pharmaceuticals, Inc., Baudette, MN
Quantity
5,477 bottles
Distribution
Nationwide within the United States
Type
Voluntary: Firm initiated
Recall initiated
February 15, 2022
Terminated
October 25, 2022