FDA recall D-0568-2022

ANI Pharmaceuticals, Inc. · Class II · drug

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

Distribution

Nationwide within the United States

Key facts

Status: Terminated
Initiation date: 2022-02-15
Report date: 2022-02-23
Termination date: 2022-10-25
Voluntary/Mandated: Voluntary: Firm initiated
Location: Baudette, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0568-2022