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), 88 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1329-01
Lot numbers, UPCs & expiration codes
Lot #: 1098967, 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-436-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 1, 2013
- FDA report date
- May 29, 2013
- Quantity
- 12,156 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lloyd Inc. of Iowa
Original FDA data
Every field from FDA enforcement report D-436-2013, 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 #: 1098967, Exp. Mar-13.
- Postal code
- 51601-1744
- Report date
- May 29, 2013
- Product type
- Drugs
- Recall number
- D-436-2013
- Classification
- Class II
- Recalling firm
- Lloyd Inc. of Iowa
- Product quantity
- 12,156 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), 88 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1329-01
- 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