Drug product
Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/10 mg, packaged in a) 100-count bottles (NDC 0378-6896-01) and b) 500-count bottles (NDC 0378-6896-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
D-66403-006
Product summary
- Event
- Event 66403
- Status
- Terminated
- Classification
- Class II
- Quantity
- 30,878 bottles
- Official record key
drug-enforcement:D-66403-006
Official wording
Reason: CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Code information: Lot #: a) 2003159, 2003160, 2003161, 3043492; b) 2003158, 2003159, 3043492
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Manufacturing or process control
CGMP Deviations