The Recall Desk
LowFDA (Drugs)·D-1441-2012·Announced 2012-08-08

Axcentria Recalls Infants' Mapap Due to Incorrect Expiration Date Labeling

Axcentria Pharmaceuticals LLC is recalling 13,128 bottles of Infants' Mapap in Michigan because the outer packaging displays an incorrect expiration date.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The issue is a minor labeling error regarding the expiration date, fitting the criteria for a Low severity score.

Plain-English summary

Axcentria Pharmaceuticals LLC is recalling 13,128 bottles of Major brand Infants' Mapap, Acetaminophen Concentrated Drops, 1 FL. OZ. (30 mL.) 80 mg. per 0.8 mL, Cherry Flavor. The product is distributed by MAJOR PHARMACEUTICALS in Livonia, MI, and carries the NDC 0904-5255-30. The specific lot affected is D12044.

The recall was initiated due to a labeling error where the outer packaging incorrectly states the expiration date as 5/2014, whereas the correct date is 4/2014. This discrepancy is limited to the printed expiration date on the packaging.

The affected units were distributed in Michigan. Consumers who possess this specific lot of the product should check the expiration date on the outer packaging and contact the recalling firm or their healthcare provider for further instructions.

The recalled product

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,
Affected units
13,128

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Lot D12044
  • Exp 4/2014
  • NDC 0904-5255-30

Distribution

Distributed in 1 state:

Same manufacturer · Axcentria Pharmaceuticals LLC

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