Status
Terminated
Drug Enforcement D-66403-009
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
- Amlodipine Besylate and Benazepril HCl Capsules, 10mg/20mg, in 100 count bottles (NDC# 0378-6898-01) and 500 count bottles (NDC# 0378-6898-05) labeled in part ***Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.***
- Product quantity
- 42,174 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-66403-009
- Event ID
- 66403
- Recall initiation date
- September 13, 2013
- Center classification date
- November 4, 2013
- Code info
- Lot #: a) 2003177, 2003178, 2003179, 2003180, 3043496; b) 2003176, 2003177, 3043496
- More code info
- —