Cardizem 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.
Reported: February 20, 2019 Initiated: January 30, 2019 #D-0489-2019
Product Description
Cardizem 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.
Reason for Recall
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Details
- Recalling Firm
- Valeant Pharmaceuticals North America LLC
- Units Affected
- 390 bottles
- Distribution
- Nationwide in the USA and Puerto Rico
- Location
- Bridgewater, NJ
Frequently Asked Questions
What product was recalled? ▼
Cardizem 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.. Recalled by Valeant Pharmaceuticals North America LLC. Units affected: 390 bottles.
Why was this product recalled? ▼
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 20, 2019. Severity: Low. Recall number: D-0489-2019.
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