Skip to content
Recall Observatory FDA recall evidence

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,

D-1441-2012

July 12, 2012

Class III

Product summary

Firm
Axcentria Pharmaceuticals LLC
Event
Event 62628
Status
Terminated
Classification
Class III
Quantity
13,128 bottles
Official record key
drug-enforcement:D-1441-2012

Official wording

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

Code information: Lot D12044, Exp 4/2014, NDC 0904-5255-30

Distribution pattern: Michigan

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling; labeled with incorrect EXP Date; Incorrect