Liptruzet (ezetimibe and atorvastin) tablets,10 mg/40 mg, a) 30 count blister (NDC 66582-322-3...
FDA Drug Recall #D-1311-2014 — Class III — January 13, 2014
Recall Summary
| Recall Number | D-1311-2014 |
| Classification | Class III — Low risk |
| Date Initiated | January 13, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Merck & Co Inc |
| Location | Whitehouse Station, NJ |
| Product Type | Drugs |
| Quantity | 36,493 cartons |
Product Description
Liptruzet (ezetimibe and atorvastin) tablets,10 mg/40 mg, a) 30 count blister (NDC 66582-322-30), b) 90 count blister (NDC 66582-322-54), Rx only, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc, Whitehouse Station, NJ 08889
Reason for Recall
This recall of LIPTRUZET is being initiated due to packaging defects. Some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product.
Distribution Pattern
Nationwide and Puerto Rico
Lot / Code Information
a) Liptruzet 10/40mg 30 count, 346304, 346342, 350256, 353107, 353108, 353109, Exp. 06/14; 353110, Exp.12/14 b) Liptruzet 10/40mg 90 count 346382, Exp. 06/14; 353186, Exp.12/14.
Other Recalls from Merck & Co Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-1310-2014 | Class III | Liptruzet (ezetimibe and atorvastin) tablets,10... | Jan 13, 2014 |
| D-1309-2014 | Class III | Liptruzet (ezetimibe and atorvastin) tablets,10... | Jan 13, 2014 |
| D-1312-2014 | Class III | Liptruzet (ezetimibe and atorvastin) tablets,10... | Jan 13, 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.