Cartia XT (diltiazem HCl extended-release capsules, USP), Once-A-Day Dosage, 300 mg, 90-count bot...

FDA Drug Recall #D-0488-2015 — Class III — March 26, 2015

Recall Summary

Recall Number D-0488-2015
Classification Class III — Low risk
Date Initiated March 26, 2015
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Actavis Laboratories, FL, Inc.
Location Davie, FL
Product Type Drugs
Quantity 2,628 bottles

Product Description

Cartia XT (diltiazem HCl extended-release capsules, USP), Once-A-Day Dosage, 300 mg, 90-count bottles, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA --- NDC 62037-0600-90

Reason for Recall

Presence of Foreign Substance; fine residue or dust identified as aluminum may be on exterior of the capsule shell

Distribution Pattern

Nationwide

Lot / Code Information

Lot # 956000M, Exp. Aug 2016; UPC 3-6203760090-6

Other Recalls from Actavis Laboratories, FL, Inc.

Recall # Classification Product Date
D-0118-2017 Class III Ramipril Capsules, USP, 1.25 mg, 30-count bottl... Aug 30, 2016
D-0014-2016 Class II Metformin Hydrochloride Extended-Release Tablet... Sep 25, 2015
D-1285-2015 Class III Desmopressin Acetate Tablets, 0.1mg, 100 Count ... Jun 23, 2015
D-0258-2015 Class II Diclofenac Sodium and Misoprostol Delayed-Relea... Sep 26, 2014
D-1616-2014 Class II Diclofenac Sodium and Misoprostol Delayed-Relea... Apr 24, 2014

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.