FDA Recall Terminated Historical recordClass III
Cardizem CD (diltiazem HCl) capsules, 240 mg, packaged in a) 30-count bottles (NDC 0187-0797-30); and b) 90-count bottles (NDC 0187-0797-42), Rx Only, Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA; By: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7, Canada.
- Reason
- Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
- Published
- February 20, 2019
- Distribution
- Nationwide
