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.
Recall Number: D-0491-2019
Firm: Valeant Pharmaceuticals North America LLC
Classification: Class III
Status: Terminated
Report Date: 20190220
Initiation Date: 20190130
Termination Date: 20200708
Reason for Recall
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Product Description
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.