Why it was recalled
Subpotent (Single Ingredient Drug): Low assay at the 9-month test interval.
Product description
Levothroid (levothyroxine sodium tablets, USP), 50 mcg., packaged in 100-ct. bottles, RX, NDC 0456-1321-01. Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.
Lot numbers, UPCs & expiration codes
Lot 1087589
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-1393-2012
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 3, 2012
- FDA report date
- Jul 4, 2012
- Quantity
- 19,166 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lloyd Inc
Original FDA data
Every field from FDA enforcement report D-1393-2012, exactly as published.
Show all FDA fields
- City
- Shenandoah
- State
- IA
- Status
- Terminated
- Country
- United States
- Event ID
- 61094
- Address
- 604 W Thomas Ave
- Address (line 2)
- Po Box 130
- Code information
- Lot 1087589
- Postal code
- 51601-1744
- Report date
- Jul 4, 2012
- Product type
- Drugs
- Recall number
- D-1393-2012
- Classification
- Class II
- Recalling firm
- Lloyd Inc
- Product quantity
- 19,166 bottles
- Termination date
- Jul 30, 2013
- Reason for recall
- Subpotent (Single Ingredient Drug): Low assay at the 9-month test interval.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Levothroid (levothyroxine sodium tablets, USP), 50 mcg., packaged in 100-ct. bottles, RX, NDC 0456-1321-01. Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.
- Distribution pattern
- Nationwide and PR.
- Recall initiation date
- Feb 3, 2012
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Jun 22, 2012