Why it was recalled
Subpotent Drug: The products were below specification for potency at the expiry stability point.
Product description
Levoxyl (levothyroxine sodium) tablets, USP, 137 mcg, packaged in a) 100-count bottles (NDC 60793-857-01) and b) 1000-count bottles (NDC 60793-857-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620
Lot numbers, UPCs & expiration codes
Lot # a) 64190, Exp. 4/13; 64331, Exp. 6/13; 65642, Exp. 7/13; and 66297, Exp. 9/13; b) 64326, Exp. 4/13; 64332, Exp. 6/13; and 65771, Exp. 7/13
Where it was sold
Nationwide and Puerto Rico
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-428-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 30, 2013
- FDA report date
- May 29, 2013
- Quantity
- 77,272 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- King Legacy, a wholly owned subsidiary of Pfizer
Original FDA data
Every field from FDA enforcement report D-428-2013, exactly as published.
Show all FDA fields
- City
- Bristol
- State
- TN
- Status
- Terminated
- Country
- United States
- Event ID
- 65172
- Address
- 501 5th Street
- Code information
- Lot # a) 64190, Exp. 4/13; 64331, Exp. 6/13; 65642, Exp. 7/13; and 66297, Exp. 9/13; b) 64326, Exp. 4/13; 64332, Exp. 6/13; and 65771, Exp. 7/13
- Postal code
- 37620-2304
- Report date
- May 29, 2013
- Product type
- Drugs
- Recall number
- D-428-2013
- Classification
- Class II
- Recalling firm
- King Legacy, a wholly owned subsidiary of Pfizer
- Product quantity
- 77,272 bottles
- Termination date
- Jun 30, 2016
- Reason for recall
- Subpotent Drug: The products were below specification for potency at the expiry stability point.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Levoxyl (levothyroxine sodium) tablets, USP, 137 mcg, packaged in a) 100-count bottles (NDC 60793-857-01) and b) 1000-count bottles (NDC 60793-857-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Apr 30, 2013
- Initial firm notification
- Letter
- Center classification date
- May 20, 2013