Drug product
Amlodipine Besylate Tablets, USP, 2.5 mg, packaged in a) 90-count bottles (NDC 0378-5208-77) and b) 500-count bottles (NDC 0378-5208-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
D-66403-001
Product summary
- Event
- Event 66403
- Status
- Terminated
- Classification
- Class II
- Quantity
- 37,752 bottles
- Official record key
drug-enforcement:D-66403-001
Official wording
Reason: CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Code information: Lot #: a) 3037907, 3040106; b) 3037907, 3040106, 3044357
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Manufacturing or process control
CGMP Deviations