Recalls / Class II
Class IID-066-2013
Product
Mylan, Tacrolimus Capsules 0.5 mg, 100 count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-2045-01
- Brand name
- Tacrolimus
- Generic name
- Tacrolimus
- Active ingredient
- Tacrolimus
- Route
- Oral
- NDCs
- 0378-2045, 0378-2046, 0378-2047
- FDA application
- ANDA090596
- Affected lot / code info
- Lots: 3027684 Exp. 5/13, 3027688 Exp. 6/13 2002157 Exp. 9/12
Why it was recalled
Failed USP Content Uniformity Requirements: OOS result reported on retained samples.
Recalling firm
- Firm
- Mylan LLC.
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Road #156, Km. 58.8, Lot 24B, N/A, Caguas, Puerto Rico 00725
Distribution
- Quantity
- 15181 bottles.
- Distribution pattern
- Natiowide
Timeline
- Recall initiated
- 2012-06-29
- FDA classified
- 2012-11-26
- Posted by FDA
- 2012-12-05
- Terminated
- 2017-04-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-066-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.