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  3. Recall Enforcement Event ID: 82021

Recall Enforment Report D-0491-2019

Recall Details

Multi event Drug Recall Enforcement Report Class III voluntary initiated by Valeant Pharmaceuticals North America LLC, originally initiated on 01-30-2019 for the product Diltiazem HCl CD capsules, 360 mg, 90-count bottles, Rx Only, Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA; By: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7 Canada; NDC 68682-521-01. The product was recalled due to failed dissolution specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.. The product was distributed nationwide and the recall is currently terminated.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0491-201901-30-201902-20-2019Class III23,884 bottlesDiltiazem HCl CD capsules, 360 mg, 90-count bottles, Rx Only, Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA; By: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7 Canada; NDC 68682-521-01.Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.Terminated
D-0488-201901-30-201902-20-2019Class III206 bottlesCardizem 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.Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.Terminated
D-0487-201901-30-201902-20-2019Class III1023 bottlesCardizem CD (diltiazem HCl) capsules, 120 mg, packaged in a) 30-count bottles (NDC 0187-0795-30); and b) 90-count bottles (NDC 0187-0795-42), Rx Only, Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA; By: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7, Canada.Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.Terminated
D-0489-201901-30-201902-20-2019Class III390 bottlesCardizem 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.Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.Terminated
D-0490-201901-30-201902-20-2019Class III22 bottlesCardizem 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.Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.Terminated

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
0187-0795Cardizem Cd Diltiazem HydrochlorideCapsule, Coated, Extended ReleaseOralBausch Health Us LlcHuman Prescription Drug
0187-0796Cardizem Cd Diltiazem HydrochlorideCapsule, Coated, Extended ReleaseOralBausch Health Us LlcHuman Prescription Drug
0187-0797Cardizem Cd Diltiazem HydrochlorideCapsule, Coated, Extended ReleaseOralBausch Health Us LlcHuman Prescription Drug
0187-0798Cardizem Cd Diltiazem HydrochlorideCapsule, Coated, Extended ReleaseOralBausch Health Us LlcHuman Prescription Drug
0187-0799Cardizem Cd Diltiazem HydrochlorideCapsule, Coated, Extended ReleaseOralBausch Health Us LlcHuman Prescription Drug
68682-521Diltiazem Hcl Cd Diltiazem HydrochlorideCapsule, Coated, Extended ReleaseOralOceanside PharmaceuticalsHuman Prescription Drug