Status
Terminated
Drug Enforcement D-066-2013
Failed USP Content Uniformity Requirements: OOS result reported on retained samples.
Classification
Class II
Report Date
December 5, 2012
Termination Date
April 13, 2017
Product Information
- Product description
- Mylan, Tacrolimus Capsules 0.5 mg, 100 count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-2045-01
- Product quantity
- 15181 bottles.
- Reason for recall
- Failed USP Content Uniformity Requirements: OOS result reported on retained samples.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Natiowide
Location & Firm
- Recalling firm
- Mylan LLC.
- Address
-
Road #156, Km. 58.8, Lot 24B, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-066-2013
- Event ID
- 62454
- Recall initiation date
- June 29, 2012
- Center classification date
- November 26, 2012
- Code info
- Lots: 3027684 Exp. 5/13, 3027688 Exp. 6/13 2002157 Exp. 9/12
- More code info
- —