FDA recall D-1013-2019

Mylan Institutional, Inc. (d.b.a. UDL Laboratories) · Class II · drug

Product

Alprazolam Tablets, USP, 0.25 mg, 10x10 per carton, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 51079-788-20

Reason for recall

Failed Impurities/Degradation Specifications: Elevated levels of a known impurity detected during 6-month RT stability interval.

Distribution

Nationwide USA and Puerto Rico

Key facts

Status: Terminated
Initiation date: 2019-01-18
Report date: 2019-03-27
Termination date: 2020-04-29
Voluntary/Mandated: Voluntary: Firm initiated
Location: Rockford, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1013-2019