Drug 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.
D-107-2013
Product summary
- Event
- Event 63791
- Status
- Terminated
- Classification
- Class II
- Quantity
- 28, 524 bottles
- Official record key
drug-enforcement:D-107-2013
Official wording
Reason: Labeling: Error on Declared Strength. Product labeled to contain 150 mcg tablets actually contained 75 mcg tablets.
Code information: LOT # 18262A8 Exp. 09/13
Distribution pattern: US Nationwide and Puerto Rico
Derived failure modes
-
Labeling or packaging
Labeling: Error