Drug product
Diltiazem HCl Extended-Release Capsules, USP 120 mg, 100-count bottles, Rx only, Mfg. By: Par Pharmaceutical One Ram Ridge Rd Chestnut Ridge, NY 10977. NDC: 63739-014-10
D-0714-2018
Product summary
- Event
- Event 79936
- Status
- Terminated
- Classification
- Class III
- Quantity
- 4266 cartons
- Official record key
drug-enforcement:D-0714-2018
Official wording
Reason: Failed Dissolution Specifications. High dissolution results were obtained during stability testing.
Code information: Lot #: 0115086, Exp. 12/2018
Distribution pattern: Nationwide with the US
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications