Product: Cardizem CD (diltiazem HCl) capsules, 300 mg, packaged in a) 30-count bottles (NDC 0187-0798-30); and b) 90-count bottles (NDC 0187-0798-42), Rx Only, Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA; By: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7, Canada.
Reason for recall: Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Recall initiated: 20190130
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated