PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: December 5, 2012 Initiated: June 29, 2012 #D-066-2013

Product Description

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.

Details

Recalling Firm
Mylan LLC.
Units Affected
15181 bottles.
Distribution
Natiowide
Location
Caguas, PR

Frequently Asked Questions

What product was recalled?
Mylan, Tacrolimus Capsules 0.5 mg, 100 count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-2045-01. Recalled by Mylan LLC.. Units affected: 15181 bottles..
Why was this product recalled?
Failed USP Content Uniformity Requirements: OOS result reported on retained samples.
Which agency issued this recall?
This recall was issued by the FDA Drug on December 5, 2012. Severity: Moderate. Recall number: D-066-2013.