Cardizem Cd Capsule, Coated, Extended Release
FDA Recall NDC 0187-0797
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 4 recorded enforcement report(s) associated with Cardizem Cd (NDC 0187-0797). A significant event, classified as Class III, was initiated on Jan 30, 2019 by Bausch Health Us Llc. The reported reason for this action was: "Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Jan 30, 2019
Feb 20, 2019
206 bottles
Recall Profile & Regulatory Data
Event ID
82021
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Valeant Pharmaceuticals North America LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA and Puerto Rico
Termination Date
Jul 08, 2020
Product Description
Cardizem CD (diltiazem HCl) capsules, 180 mg, packaged in a) 30-count bottles (NDC 0187-0796-30); and b) 90-count bottles (NDC 0187-0796-42), Rx Only, Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA; By: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7, Canada.
Batch or Lot Expiration Information
Lot# Lots: a) 18J018P, Exp 08/2020; b) 18J029P, Exp 08/2020
Affected Packages Involved in this Recall
0187-0795-30Product
0187-0795-42Product
0187-0795-49Product
0187-0796-30Product
0187-0796-42Product
0187-0796-49Product
0187-0796-50Product
0187-0797-30Product
0187-0797-42Product
0187-0797-49Product
0187-0798-30Product
0187-0798-42Product
0187-0799-42Product
Class III Terminated
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Jan 30, 2019
Feb 20, 2019
1023 bottles
Recall Profile & Regulatory Data
Event ID
82021
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Valeant Pharmaceuticals North America LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA and Puerto Rico
Termination Date
Jul 08, 2020
Product Description
Cardizem CD (diltiazem HCl) capsules, 120 mg, packaged in a) 30-count bottles (NDC 0187-0795-30); and b) 90-count bottles (NDC 0187-0795-42), Rx Only, Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA; By: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7, Canada.
Batch or Lot Expiration Information
Lot# Lots: a) 18J023P, Exp 08/2020; b) 18J021P, Exp 08/2020
Affected Packages Involved in this Recall
0187-0795-30Product
0187-0795-42Product
0187-0795-49Product
0187-0796-30Product
0187-0796-42Product
0187-0796-49Product
0187-0796-50Product
0187-0797-30Product
0187-0797-42Product
0187-0797-49Product
0187-0798-30Product
0187-0798-42Product
0187-0799-42Product
Class III Terminated
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Jan 30, 2019
Feb 20, 2019
390 bottles
Recall Profile & Regulatory Data
Event ID
82021
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Valeant Pharmaceuticals North America LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA and Puerto Rico
Termination Date
Jul 08, 2020
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.
Batch or Lot Expiration Information
Lot# Lots: a) 18J019P, Exp 08/2020; b) 18J028P, Exp 08/2020
Affected Packages Involved in this Recall
0187-0795-30Product
0187-0795-42Product
0187-0795-49Product
0187-0796-30Product
0187-0796-42Product
0187-0796-49Product
0187-0796-50Product
0187-0797-30Product
0187-0797-42Product
0187-0797-49Product
0187-0798-30Product
0187-0798-42Product
0187-0799-42Product
Class III Terminated
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Jan 30, 2019
Feb 20, 2019
22 bottles
Recall Profile & Regulatory Data
Event ID
82021
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Valeant Pharmaceuticals North America LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA and Puerto Rico
Termination Date
Jul 08, 2020
Product Description
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.
Batch or Lot Expiration Information
Lot# Lots: a)18J020P, Exp 08/2020; b) 18J034P, Exp 08/2020
Affected Packages Involved in this Recall
0187-0795-30Product
0187-0795-42Product
0187-0795-49Product
0187-0796-30Product
0187-0796-42Product
0187-0796-49Product
0187-0796-50Product
0187-0797-30Product
0187-0797-42Product
0187-0797-49Product
0187-0798-30Product
0187-0798-42Product
0187-0799-42Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
