Drug product
AMLODIPINE BESYLATE TABLETS USP, 10 mg*, 1000 count bottles (NDC 0603-2110-32), Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811
D-0397-2015
Product summary
- Event
- Event 70503
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2808 bottles
- Official record key
drug-enforcement:D-0397-2015
Official wording
Reason: Failed tablet specifications: One lot was found to contain oversized tablets.
Code information: Lot T018H14A, Exp 08/16
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Failed tablet specifications: One lot was found to contain oversized tablets.