Valeant Pharmaceuticals North America LLC recalls Cardizem CD (diltiazem HCl) capsules, 240 mg, packaged in a) 30-count bottles (NDC 0187-0797-30); and b) 90-count bottle
Recalled February 20, 2019 · FDA recall D-0489-2019 · Valeant Pharmaceuticals North America
Hazard
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points. · FDA Class III
Units
390 bottles
Sold at
Nationwide in the USA and Puerto Rico
Description
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Product
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.
Manufacturer(s)
Valeant Pharmaceuticals North America LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →