FDA recall D-428-2013

King Legacy, a wholly owned subsidiary of Pfizer · Class II · drug

Product

Levoxyl (levothyroxine sodium) tablets, USP, 137 mcg, packaged in a) 100-count bottles (NDC 60793-857-01) and b) 1000-count bottles (NDC 60793-857-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620

Reason for recall

Subpotent Drug: The products were below specification for potency at the expiry stability point.

Distribution

Nationwide and Puerto Rico

Key facts

Status: Terminated
Initiation date: 2013-04-30
Report date: 2013-05-29
Termination date: 2016-06-30
Voluntary/Mandated: Voluntary: Firm initiated
Location: Bristol, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-428-2013