Status
Terminated
Drug Enforcement D-66403-011
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Classification
Class II
Report Date
November 13, 2013
Termination Date
July 23, 2015
Product Information
- Product description
- Ciprofloxacin Tablets, USP, 500 mg,100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A, NDC 0378-7098-01
- Product quantity
- 941,270 bottles
- Reason for recall
- CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide and Puerto Rico
Location & Firm
- Recalling firm
- Mylan Pharmaceuticals Inc.
- Address
-
781 Chestnut Ridge Rd, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-66403-011
- Event ID
- 66403
- Recall initiation date
- September 13, 2013
- Center classification date
- November 4, 2013
- Code info
- Lot #: 2002732, 2002733, 2002734, 2002735, 2002736, 2002737, 2002738, 2002739, 2002740, 2002741, 2002742, 2002743, 2002744, 2002745, 3030000, 3030001, 3030002, 3030003, 3030004, 3030005, 3030006, 3030016, 3030017, 3030018, 3030216, 3030217, 3030218, 3030219, 3030220, 3030221, 3030222, 3030223, 3030224, 3030225, 3030226, 3030227, 3030228, 3030229, 3030238, 3030351, 3030352, 3030354, 3030355, 3030356, 3030357, 3030358, 3031790, 3031792, 3031793, 3031794, 3031795, 3031796, 3031797, 3031798, 3032035, 3032036, 3032037, 3032038, 3032039, 3032040, 3032041, 3032042, 3032043, 3032044, 3032045, 3032046
- More code info
- —