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.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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,
- Manufacturer
- Axcentria Pharmaceuticals LLC
- Category
- Drug — Infant Medication
- Hazard
- 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:
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