Drug product
Diltiazem CD (Diltiazem Hydrochloride Extended-Release Capsules, USP) 180 mg, 100-count bottles, Rx Only Mfg. By: Actavis 60 Columbia Rd., Bldg. B Morristown, NJ 07960. NDC 63739-284-10
D-0715-2018
Product summary
- Event
- Event 79936
- Status
- Terminated
- Classification
- Class III
- Quantity
- 7656 cartons
- Official record key
drug-enforcement:D-0715-2018
Official wording
Reason: Failed Dissolution Specifications. High dissolution results were obtained during stability testing.
Code information: Lot #: 0114214, Exp. 09/2018
Distribution pattern: Nationwide with the US
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications