FDA recall D-0642-2022

Product

Alprazolam Tablets, USP 1mg, Generic for Xanax, Pkg Size: a) 30 tablets per bottle, NDC: 68788-6381-03, b) 60 tablets per bottle, NDC: 68788-6381-06, c) 90 tablets per bottle, NDC: 68788-6381-09, Mfg: Par Pharmaceutical.

Reason for recall

CGMP deviations

Distribution

Nationwide in the USA.

Key facts

Status

Terminated

Initiation date

2022-02-22

Report date

2022-03-09

Termination date

2023-05-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Anaheim, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0642-2022