Why it was recalled
Chemical contamination: emission of strong odor after package was opened..
Product description
Levoxyl (levothyroxine sodium) tablets, USP 88 mcg, packaged in a) 100-count bottles (NDC 60793-853-01) and b) 1000-count bottles ( NDC 60793-853-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.
Lot numbers, UPCs & expiration codes
Lot # a) 66619B, Exp. 11/13; 67010B, Exp. 01/14; b) 66733B, Exp. 11/13; 67441B, Exp. 01/14
Where it was sold
Nationwide and PR
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-254-2013
- Classification
- Class II
- Status
- Completed
- Recall initiated
- Mar 28, 2013
- FDA report date
- Apr 24, 2013
- Quantity
- 26447 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pfizer Inc.
Original FDA data
Every field from FDA enforcement report D-254-2013, exactly as published.
Show all FDA fields
- City
- New York
- State
- NY
- Status
- Completed
- Country
- United States
- Event ID
- 64835
- Address
- 235 East 42nd Street
- Code information
- Lot # a) 66619B, Exp. 11/13; 67010B, Exp. 01/14; b) 66733B, Exp. 11/13; 67441B, Exp. 01/14
- Postal code
- 10017-5703
- Report date
- Apr 24, 2013
- Product type
- Drugs
- Recall number
- D-254-2013
- Classification
- Class II
- Recalling firm
- Pfizer Inc.
- Product quantity
- 26447 bottles
- Reason for recall
- Chemical contamination: emission of strong odor after package was opened..
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Levoxyl (levothyroxine sodium) tablets, USP 88 mcg, packaged in a) 100-count bottles (NDC 60793-853-01) and b) 1000-count bottles ( NDC 60793-853-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.
- Distribution pattern
- Nationwide and PR
- Recall initiation date
- Mar 28, 2013
- Initial firm notification
- Letter
- Center classification date
- Apr 18, 2013