Cardizem CD (diltiazem HCl) capsules, 180 mg, packaged in a) 30-count bottles (NDC 0187-0796-30);...

FDA Drug Recall #D-0488-2019 — Class III — January 30, 2019

Recall Summary

Recall Number D-0488-2019
Classification Class III — Low risk
Date Initiated January 30, 2019
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Valeant Pharmaceuticals North America LLC
Location Bridgewater, NJ
Product Type Drugs
Quantity 206 bottles

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.

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

Lot / Code Information

Lots: a) 18J018P, Exp 08/2020; b) 18J029P, Exp 08/2020

Other Recalls from Valeant Pharmaceuticals North America...

Recall # Classification Product Date
D-0487-2019 Class III Cardizem CD (diltiazem HCl) capsules, 120 mg, p... Jan 30, 2019
D-0490-2019 Class III Cardizem CD (diltiazem HCl) capsules, 300 mg, p... Jan 30, 2019
D-0491-2019 Class III Diltiazem HCl CD capsules, 360 mg, 90-count bot... Jan 30, 2019
D-0489-2019 Class III Cardizem CD (diltiazem HCl) capsules, 240 mg, p... Jan 30, 2019
D-0084-2019 Class II Cortaid Intensive Therapy Cooling Spray (1% hyd... Aug 24, 2018

Frequently Asked Questions

Stop taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping — abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects to FDA MedWatch at 1-800-FDA-1088.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.