D-0491-2019 Class III Terminated
FDA drug recall D-0491-2019 was initiated by Valeant Pharmaceuticals North America LLC on January 30, 2019 and is designated Class III. Reason for recall: Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points. The recall status is terminated (terminated July 8, 2020). Affected quantity: 23,884 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- February 20, 2019
- Initiation Date
- January 30, 2019
- Termination Date
- July 8, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 23,884 bottles
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.
Reason for Recall
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Distribution Pattern
Nationwide in the USA and Puerto Rico
Code Information
Lots: 18J035P, 18K094P, 18K093P, Exp 09/2020