FDA recall D-0565-2022

Product

Alprazolam Tablets, USP 0.5 mg, packaged in a) 100-count bottles (NDC 67253-901-10), b) 500-count bottles (NDC 67253-901-50), and c) 1000-count bottles (NDC 67253-901-11), 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-0565-2022