Recalls / Class II
Class IID-107-2013
Product
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.
- Brand name
- Synthroid
- Generic name
- Levothyroxine Sodium
- Active ingredient
- Levothyroxine Sodium
- Route
- Oral
- NDCs
- 0074-3727, 0074-4341, 0074-4552, 0074-5182, 0074-6594, 0074-6624, 0074-9296, 0074-7068, 0074-7069, 0074-7070 +2 more
- FDA application
- NDA021402
- Affected lot / code info
- LOT # 18262A8 Exp. 09/13
Why it was recalled
Labeling: Error on Declared Strength. Product labeled to contain 150 mcg tablets actually contained 75 mcg tablets.
Recalling firm
- Firm
- Abbott Laboratories
- Manufacturer
- AbbVie Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 100 Abbott Park Rd, N/A, Abbott Park, Illinois 60064-3502
Distribution
- Quantity
- 28, 524 bottles
- Distribution pattern
- US Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2012-12-04
- FDA classified
- 2012-12-28
- Posted by FDA
- 2013-01-09
- Terminated
- 2015-07-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-107-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.