FDA recall D-107-2013

Abbott Laboratories · Class II · 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.

Reason for recall

Labeling: Error on Declared Strength. Product labeled to contain 150 mcg tablets actually contained 75 mcg tablets.

Distribution

US Nationwide and Puerto Rico

Key facts

Status: Terminated
Initiation date: 2012-12-04
Report date: 2013-01-09
Termination date: 2015-07-10
Voluntary/Mandated: Voluntary: Firm initiated
Location: Abbott Park, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-107-2013