Drug product
Cardizem CD (diltiazem HCl) capsules, 180 mg, packaged in a) 30-count bottles (NDC 0187-0796-30); and b) 90-count bottles (NDC 0187-0796-42), Rx Only, Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA; By: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7, Canada.
D-0488-2019
Product summary
- Event
- Event 82021
- Status
- Terminated
- Classification
- Class III
- Quantity
- 206 bottles
- Official record key
drug-enforcement:D-0488-2019
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: a) 18J018P, Exp 08/2020; b) 18J029P, Exp 08/2020
Distribution pattern: Nationwide in the USA and Puerto Rico
Derived failure modes
-
Potency or specification failure
out of specification