Drug recall D-066-2013
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.
Lots and codes
Lots: 3027684 Exp. 5/13, 3027688 Exp. 6/13 2002157 Exp. 9/12
Recall details
- Recalling firm
- Mylan LLC., Caguas, PR
- Quantity
- 15181 bottles.
- Distribution
- Natiowide
- Type
- Voluntary: Firm initiated
- Recall initiated
- June 29, 2012
- Terminated
- April 13, 2017
Related products
- Tacrolimus – drug information
- NDC 0378-2046 Tacrolimus · Tacrolimus 1 mg/1 · Mylan Pharmaceuticals Inc.
- NDC 0378-2047 Tacrolimus · Tacrolimus 5 mg/1 · Mylan Pharmaceuticals Inc.
- NDC 0378-2045 Tacrolimus · Tacrolimus .5 mg/1 · Mylan Pharmaceuticals Inc.