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.