Why it was recalled
cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
Product description
Levothroid (levothyroxine sodium tablets, USP) , 50 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1321-01
Lot numbers, UPCs & expiration codes
Lot #: 1098751, Exp. Mar-13
Where it was sold
The firm distributed the bulk product to Forest Laboratories, Inc, St. Louis, MO who repackaged the product into 100-tablet bottles and distribution was made to 75 customers 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-432-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 1, 2013
- FDA report date
- May 29, 2013
- Quantity
- 4,440 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lloyd Inc. of Iowa
Original FDA data
Every field from FDA enforcement report D-432-2013, exactly as published.
Show all FDA fields
- City
- Shenandoah
- State
- IA
- Status
- Terminated
- Country
- United States
- Event ID
- 65154
- Address
- 604 W Thomas Ave
- Code information
- Lot #: 1098751, Exp. Mar-13
- Postal code
- 51601-1744
- Report date
- May 29, 2013
- Product type
- Drugs
- Recall number
- D-432-2013
- Classification
- Class II
- Recalling firm
- Lloyd Inc. of Iowa
- Product quantity
- 4,440 Bottles
- Termination date
- May 8, 2014
- Reason for recall
- cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Levothroid (levothyroxine sodium tablets, USP) , 50 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1321-01
- Distribution pattern
- The firm distributed the bulk product to Forest Laboratories, Inc, St. Louis, MO who repackaged the product into 100-tablet bottles and distribution was made to 75 customers Nationwide and Puerto Rico.
- Recall initiation date
- Apr 1, 2013
- Initial firm notification
- Letter
- Center classification date
- May 21, 2013