Why it was recalled
Labeling: Error on Declared Strength. Product labeled to contain 150 mcg tablets actually contained 75 mcg tablets.
Product description
Synthroid (Levothyroxine Sodium) tablets, 150 mcg (0.15 mg), 90 tablets per bottle, Rx Only, NDC 0074-7069-90; ABBOTT LABORATORIES NORTH CHICAGO, IL 60064 U.S.A.
Lot numbers, UPCs & expiration codes
LOT # 18262A8 Exp. 09/13
Where it was sold
US 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-107-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 4, 2012
- FDA report date
- Jan 9, 2013
- Quantity
- 28, 524 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Abbott Laboratories
Original FDA data
Every field from FDA enforcement report D-107-2013, exactly as published.
Show all FDA fields
- City
- Abbott Park
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 63791
- Address
- 100 Abbott Park Rd
- Code information
- LOT # 18262A8 Exp. 09/13
- Postal code
- 60064-3502
- Report date
- Jan 9, 2013
- Product type
- Drugs
- Recall number
- D-107-2013
- Classification
- Class II
- Recalling firm
- Abbott Laboratories
- Product quantity
- 28, 524 bottles
- Termination date
- Jul 10, 2015
- Reason for recall
- Labeling: Error on Declared Strength. Product labeled to contain 150 mcg tablets actually contained 75 mcg tablets.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Synthroid (Levothyroxine Sodium) tablets, 150 mcg (0.15 mg), 90 tablets per bottle, Rx Only, NDC 0074-7069-90; ABBOTT LABORATORIES NORTH CHICAGO, IL 60064 U.S.A.
- Distribution pattern
- US Nationwide and Puerto Rico
- Recall initiation date
- Dec 4, 2012
- Initial firm notification
- Letter
- Center classification date
- Dec 28, 2012