FDA recall D-1287-2015

GlaxoSmithkline Consmer Healthcare · Class III · drug

Product

Panadol (acetaminophen) Extra Strength, 500 mg, a) 30 count (UPC 1-03-53100-91070-8, NDC 0135-0135-02), b) 60 count (UPC 1-03-53100-91080-7, NDC 0135-0135-03) and c) 100 count (UPC 1-03-53100-91090-6, NDC 0135-0135-04) bottles, Distributed by: GlaxoSmithKline Consumer Healthcare L.P, Moon Township, PA 15108

Reason for recall

Failed Dissolution Specifications

Distribution

Puerto Rico and Virgin Islands

Key facts

Status
Terminated
Initiation date
2015-06-30
Report date
2015-08-12
Termination date
2017-02-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Moon Township, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1287-2015