Drug recall D-0490-2019
Product
Cardizem 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.
Reason for recall
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Lots and codes
Lots: a)18J020P, Exp 08/2020; b) 18J034P, Exp 08/2020
Recall details
- Recalling firm
- Valeant Pharmaceuticals North America LLC, Bridgewater, NJ
- Quantity
- 22 bottles
- Distribution
- Nationwide in the USA and Puerto Rico
- Type
- Voluntary: Firm initiated
- Recall initiated
- January 30, 2019
- Terminated
- July 8, 2020
Related products
- Cardizem CD – drug information
- NDC 0187-0799 Cardizem CD · Diltiazem Hydrochloride 360 mg/1 · Bausch Health US LLC
- NDC 0187-0798 Cardizem CD · Diltiazem Hydrochloride 300 mg/1 · Bausch Health US LLC
- NDC 0187-0795 Cardizem CD · Diltiazem Hydrochloride 120 mg/1 · Bausch Health US LLC
- NDC 0187-0797 Cardizem CD · Diltiazem Hydrochloride 240 mg/1 · Bausch Health US LLC
- NDC 0187-0796 Cardizem CD · Diltiazem Hydrochloride 180 mg/1 · Bausch Health US LLC