Why it was recalled
Defective Container: A number of Synthroid bottles have a localized thin wall defect on the bottom which may potentially impact the stability of the tablets.
Product description
Synthroid (levothyroxine sodium) Tablets USP, 75 mcg, Rx Only, 90-Count Bottle, Abbott Laboratories, North Chicago, IL 60064, NDC: 0074-5182-90.
Lot numbers, UPCs & expiration codes
Lot: 18353A8, Exp 08/31/2013
Where it was sold
Nationwide
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-1695-2012
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 19, 2012
- FDA report date
- Oct 3, 2012
- Quantity
- 42,596 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Abbott Laboratories
Original FDA data
Every field from FDA enforcement report D-1695-2012, exactly as published.
Show all FDA fields
- City
- Abbott Park
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 62674
- Address
- 100 Abbott Park Rd
- Code information
- Lot: 18353A8, Exp 08/31/2013
- Postal code
- 60064-3502
- Report date
- Oct 3, 2012
- Product type
- Drugs
- Recall number
- D-1695-2012
- Classification
- Class II
- Recalling firm
- Abbott Laboratories
- Product quantity
- 42,596 Bottles
- Termination date
- Nov 1, 2013
- Reason for recall
- Defective Container: A number of Synthroid bottles have a localized thin wall defect on the bottom which may potentially impact the stability of the tablets.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Synthroid (levothyroxine sodium) Tablets USP, 75 mcg, Rx Only, 90-Count Bottle, Abbott Laboratories, North Chicago, IL 60064, NDC: 0074-5182-90.
- Distribution pattern
- Nationwide
- Recall initiation date
- Jul 19, 2012
- Initial firm notification
- Letter
- Center classification date
- Sep 26, 2012