Drug product
Mylan, Tacrolimus Capsules 0.5 mg, 100 count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-2045-01
D-066-2013
Product summary
- Firm
- Mylan LLC.
- Event
- Event 62454
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15181 bottles.
- Official record key
drug-enforcement:D-066-2013
Official wording
Reason: Failed USP Content Uniformity Requirements: OOS result reported on retained samples.
Code information: Lots: 3027684 Exp. 5/13, 3027688 Exp. 6/13 2002157 Exp. 9/12
Distribution pattern: Natiowide
Derived failure modes
-
Unknown
Failed USP Content Uniformity Requirements: OOS result reported on retained samples.