FDA-Drug2012-12-05Class II

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

Mylan LLC.
Hazard

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

Sold states
Natiowide
Affected count
15181 bottles.
Manufactured in
Road #156, Km. 58.8, Lot 24B, N/A, Caguas, PR, United States
Products
Mylan, Tacrolimus Capsules 0.5 mg, 100 count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-2045-01

Official notice

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

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