FDA recall D-1441-2012

Axcentria Pharmaceuticals LLC · Class III · drug

Product

Major brand Infants' Mapap, Acetaminophen Concentrated Drops, 1 FL. OZ. (30 mL.) 80 mg. per 0.8 mL, Cherry Flavor, Distributed by MAJOR PHARMACEUTICALS, Livonia, MI --- NDC 0904-5255-30,

Reason for recall

Labeling; labeled with incorrect EXP Date; Incorrect expiration date printed on the outer packaging. Package incorrectly states 5/2014 should correctly state 4/2014

Distribution

Michigan

Key facts

Status: Terminated
Initiation date: 2012-07-12
Report date: 2012-08-08
Termination date: 2013-07-16
Voluntary/Mandated: Voluntary: Firm initiated
Location: Telford, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1441-2012