Drug product
Diltiazem HCl CD capsules, 360 mg, 90-count bottles, Rx Only, Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA; By: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7 Canada; NDC 68682-521-01.
D-0491-2019
Product summary
- Event
- Event 82021
- Status
- Terminated
- Classification
- Class III
- Quantity
- 23,884 bottles
- Official record key
drug-enforcement:D-0491-2019
Official wording
Reason: Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Code information: Lots: 18J035P, 18K094P, 18K093P, Exp 09/2020
Distribution pattern: Nationwide in the USA and Puerto Rico
Derived failure modes
-
Potency or specification failure
out of specification