Why it was recalled
cGMP Deviations; does not meet in process specification requirements
Product description
Levothroid (levothyroxine sodium tablets, USP), 88 mcg., 100-count bottles, Rx only, NDC 0456-1329-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.
Lot numbers, UPCs & expiration codes
Lot #1096369, exp. 11/30/2012; and #1092046, exp. 7/31/2012
Where it was sold
Distribution was nationwide, including Puerto Rico. There was no foreign, military, or government distribution.
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-077-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 9, 2012
- FDA report date
- Dec 12, 2012
- Quantity
- 31,252/100-tablet bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lloyd Inc. of Iowa
Original FDA data
Every field from FDA enforcement report D-077-2013, exactly as published.
Show all FDA fields
- City
- Shenandoah
- State
- IA
- Status
- Terminated
- Country
- United States
- Event ID
- 62511
- Address
- 604 W Thomas Ave
- Code information
- Lot #1096369, exp. 11/30/2012; and #1092046, exp. 7/31/2012
- Postal code
- 51601-1744
- Report date
- Dec 12, 2012
- Product type
- Drugs
- Recall number
- D-077-2013
- Classification
- Class II
- Recalling firm
- Lloyd Inc. of Iowa
- Product quantity
- 31,252/100-tablet bottles
- Termination date
- Nov 14, 2013
- Reason for recall
- cGMP Deviations; does not meet in process specification requirements
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Levothroid (levothyroxine sodium tablets, USP), 88 mcg., 100-count bottles, Rx only, NDC 0456-1329-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.
- Distribution pattern
- Distribution was nationwide, including Puerto Rico. There was no foreign, military, or government distribution.
- Recall initiation date
- Jul 9, 2012
- Initial firm notification
- Telephone
- Center classification date
- Dec 3, 2012