FDA recall D-256-2013

Product

Levoxyl (levothyroxine sodium) tablets, USP 112 mcg, packaged in a) 100-count bottles (NDC 60793-855-01) and b) 1000-count bottles ( NDC 60793-855-10 ) 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-256-2013