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Class III: unlikely to cause harmTerminated

Axcentria Pharmaceuticals Major brand Infants' Mapap Recall

Major brand Infants' Mapap, Acetaminophen Concentrated Drops, 1 FL

Axcentria Pharmaceuticals LLC · Telford, PA

Risk level
Class III
Reported by FDA
Aug 8, 2012
Recall ID
D-1441-2012
Check your lot numberHow we source this data

Summary

Axcentria Pharmaceuticals recalled Major brand Infants' Mapap starting Jul 12, 2012. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-1441-2012 on Aug 8, 2012. 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. Status: Terminated.

Why it was recalled

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

Product description

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,

Lot numbers, UPCs & expiration codes

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

Where it was sold

Michigan

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-1441-2012
Classification
Class III
Status
Terminated
Recall initiated
Jul 12, 2012
FDA report date
Aug 8, 2012
Quantity
13,128 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Axcentria Pharmaceuticals LLC

Original FDA data

Every field from FDA enforcement report D-1441-2012, exactly as published.

Show all FDA fields
City
Telford
State
PA
Status
Terminated
Country
United States
Event ID
62628
Address
306 Keystone Dr
Address (line 2)
Unit B
Code information
Lot D12044, Exp 4/2014, NDC 0904-5255-30
Postal code
18969
Report date
Aug 8, 2012
Product type
Drugs
Recall number
D-1441-2012
Classification
Class III
Recalling firm
Axcentria Pharmaceuticals LLC
Product quantity
13,128 bottles
Termination date
Jul 16, 2013
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
Voluntary / mandated
Voluntary: Firm initiated
Product description
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,
Distribution pattern
Michigan
Recall initiation date
Jul 12, 2012
Initial firm notification
E-Mail
Center classification date
Aug 2, 2012

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1441-2012, published Aug 8, 2012. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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