Levoxyl (levothyroxine sodium) tablets, USP, 100 mcg, packaged in a) 100-count bottles (NDC 60793...

FDA Drug Recall #D-425-2013 — Class II — April 30, 2013

Recall Summary

Recall Number D-425-2013
Classification Class II — Moderate risk
Date Initiated April 30, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm King Legacy, a wholly owned subsidiary of Pfizer
Location Bristol, TN
Product Type Drugs
Quantity 195,201 bottles

Product Description

Levoxyl (levothyroxine sodium) tablets, USP, 100 mcg, packaged in a) 100-count bottles (NDC 60793-854-01) and b) 1000-count bottles (NDC 60793-854-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620

Reason for Recall

Subpotent Drug: The products were below specification for potency at the expiry stability point.

Distribution Pattern

Nationwide and Puerto Rico

Lot / Code Information

Lot # a) 64341, Exp 04/13; 64928, Exp. 5/13; 65064, Exp. 5/13; 65233, Exp. 7/13; 66162, Exp. 8/13; 66365, Exp. 10/13; and 66677, Exp. 11/13; b) 64342, Exp. 4/13; 64929, Exp. 5/13; 65065, Exp. 5/13; 65234, Exp. 7/13; 65539, Exp. 7/13; 65901, Exp. 8/13; and 66163, Exp. 8/13

Other Recalls from King Legacy, a wholly owned subsidiar...

Recall # Classification Product Date
D-428-2013 Class II Levoxyl (levothyroxine sodium) tablets, USP, 13... Apr 30, 2013
D-424-2013 Class II Levoxyl (levothyroxine sodium) tablets, USP, 88... Apr 30, 2013
D-430-2013 Class II Levoxyl (levothyroxine sodium) tablets, USP, 17... Apr 30, 2013
D-421-2013 Class II Levoxyl (levothyroxine sodium) tablets, USP, 25... Apr 30, 2013
D-426-2013 Class II Levoxyl (levothyroxine sodium) tablets, USP, 11... Apr 30, 2013

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.