July 2012 FDA Recall Drug by Axcentria Pharmaceuticals Llc
D-1441-2012 - Labeling; labeled with incorrect EXP Date; Incorrect expiration date printed on the outer packaging. Package incorrectly states 5/2014 should correctly state 4/2014

This Class III drug recall was voluntarily initiated by Axcentria Pharmaceuticals Llc on July 12, 2012 for the product Drug. The FDA reported the reason for recall as labeling; labeled with incorrect exp date; incorrect expiration date printed on the outer packaging. package incorrectly states 5/2014 should correctly state 4/2014. The product was distributed in Michigan and the recall is currently terminated.

Recall Number: D-1441-2012

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
Initiated
07-12-2012
Reported
08-08-2012
Quantity
13,128 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
62628
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Axcentria Pharmaceuticals LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Michigan
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-16-2013
Product Description About Product Description
Full technical description of the 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,

Batch or Lot Expiration Information

Lot# Lot D12044, Exp 4/2014, NDC 0904-5255-30