FDA recall D-259-2013

Pfizer Inc. · Class II · drug

Product

Levoxyl (levothyroxine sodium) tablets, USP 150 mcg, packaged in a) 100-count bottles (NDC 60793-858-01) and b) 1000-count bottles ( NDC 60793-858-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.

Reason for recall

Chemical contamination: emission of strong odor after package was opened.

Distribution

Nationwide and PR

Key facts

Status
Completed
Initiation date
2013-03-28
Report date
2013-04-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
New York, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-259-2013