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

FDA recall notice · announced December 5, 2012 · Mylan

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Notes

Distribution: Natiowide
Lot/code information: Lots: 3027684 Exp. 5/13, 3027688 Exp. 6/13 2002157 Exp. 9/12
Quantity: 15181 bottles.
Status: Terminated
Products in this recall event:
- Mylan, Tacrolimus Capsules 0.5 mg, 100 count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-2045-01 (D-066-2013)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.