Drug product
Amlodipine Besylate Tablets, USP 10 mg, packaged in a) 90-count bottles (NDC 0378-5210-77) and b) 500-count bottles (NDC 0378-5210-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
D-66403-012
Product summary
- Event
- Event 66403
- Status
- Terminated
- Classification
- Class II
- Quantity
- 101,450 bottles
- Official record key
drug-enforcement:D-66403-012
Official wording
Reason: CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Code information: Lot #: a) 3038984, 3038985, 3038986, 3041484, 3041485; b) 3036828, 3036829, 3036830, 3036831, 3036832, 3038987, 3038988, 3038989, 3038990, 3041480, 3041481, 3041482, 3041483, 3044522, 3044525
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Manufacturing or process control
CGMP Deviations