FDA recall D-0564-2022

ANI Pharmaceuticals, Inc. · Class II · drug

Product

Alprazolam Tablets, USP 0.25 mg, packaged in a) 100-count bottles (NDC 67253-900-10), b) 500-count bottles (NDC 67253-900-50), and c) 1000-count bottles (NDC 67253-900-11), Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977

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-0564-2022