FDA recall D-0706-2017

Product

Alprazolam Extended-release Tablets, USP, 1 mg, 60-count bottle, Rx Only, Manufactured and Distributed by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5022-91

Reason for recall

Failed Dissolution Specifications

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2016-06-22

Report date

2017-05-31

Termination date

2017-07-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Morgantown, WV, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0706-2017