Drug product
Diltiazem HCl Extended-Release Capsules, USP 240 mg, 100-count bottles, Rx Only, Mfg. By: Par Pharmaceutical One Ram Ridge Rd Chestnut Ridge, NY 10977. NDC: 63739-016-10
D-0716-2018
Product summary
- Event
- Event 79936
- Status
- Terminated
- Classification
- Class III
- Quantity
- 2966 cartons
- Official record key
drug-enforcement:D-0716-2018
Official wording
Reason: Failed Dissolution Specifications. High dissolution results were obtained during stability testing.
Code information: Lot #: 0115087, Exp. 12/2018
Distribution pattern: Nationwide with the US
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications