FDA recall D-066-2013

Mylan LLC. · Class II · drug

Product

Mylan, Tacrolimus Capsules 0.5 mg, 100 count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-2045-01

Reason for recall

Failed USP Content Uniformity Requirements: OOS result reported on retained samples.

Distribution

Natiowide

Key facts

Status: Terminated
Initiation date: 2012-06-29
Report date: 2012-12-05
Termination date: 2017-04-13
Voluntary/Mandated: Voluntary: Firm initiated
Location: Caguas, PR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-066-2013