FDA-Drug2019-02-20Class III
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.
Valeant Pharmaceuticals North America LLC
Hazard
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Sold states
Nationwide in the USA and Puerto Rico
Affected count
206 bottles
Manufactured in
400 Somerset Corporate Blvd, N/A, Bridgewater, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0488-2019Don't want to check this manually?
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