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Class II: temporary or reversible health riskTerminated

Aptalis Pharma Us SourceCF(R) Pediatric Drops Recall

SourceCF(R) Pediatric Drops, Multivitamins with A, B, D, E and K Plus Zinc, 2 FL OZ

Aptalis Pharma Us Inc · Birmingham, AL

Risk level
Class II
Reported by FDA
Mar 6, 2013
Recall ID
F-1008-2013
Check your lot numberHow we source this data

Summary

Aptalis Pharma Us recalled SourceCF(R) Pediatric Drops starting Feb 4, 2013. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report F-1008-2013 on Mar 6, 2013. Reason: The data suggests that the formulation does not support the shelf life of the product as labeled. Status: Terminated.

Why it was recalled

The data suggests that the formulation does not support the shelf life of the product as labeled.

Product description

SourceCF(R) Pediatric Drops, Multivitamins with A, B, D, E and K Plus Zinc, 2 FL OZ. (60ML), NDC 66212-300-60, UPC 668212300600

Lot numbers, UPCs & expiration codes

1BA67, exp Mar 13; 1DC02, exp Jun 13; 2BA86, exp Apr 14; 2FA92, exp Aug13.

Where it was sold

Nationwide, Italy, Canada, and Brazil

What to do if you have this product

  • Compare the brand, size, and lot/UPC codes on your package with the codes above.
  • If it matches, don't eat it. Return it to the store for a refund or throw it away.
  • Wash surfaces and containers that touched the product.
  • If you feel sick after eating it, contact your doctor. In an emergency call 911.

Recall details

Recall number
F-1008-2013
Classification
Class II
Status
Terminated
Recall initiated
Feb 4, 2013
FDA report date
Mar 6, 2013
Quantity
14439 units
Recall type
Voluntary: Firm initiated
Recalling firm
Aptalis Pharma Us Inc

Original FDA data

Every field from FDA enforcement report F-1008-2013, exactly as published.

Show all FDA fields
City
Birmingham
State
AL
Status
Terminated
Country
United States
Event ID
64245
Address
22 Inverness Center Pkwy
Address (line 2)
Ste 310
Code information
1BA67, exp Mar 13; 1DC02, exp Jun 13; 2BA86, exp Apr 14; 2FA92, exp Aug13.
Postal code
35242-4887
Report date
Mar 6, 2013
Product type
Food
Recall number
F-1008-2013
Classification
Class II
Recalling firm
Aptalis Pharma Us Inc
Product quantity
14439 units
Termination date
Jul 22, 2013
Reason for recall
The data suggests that the formulation does not support the shelf life of the product as labeled.
Voluntary / mandated
Voluntary: Firm initiated
Product description
SourceCF(R) Pediatric Drops, Multivitamins with A, B, D, E and K Plus Zinc, 2 FL OZ. (60ML), NDC 66212-300-60, UPC 668212300600
Distribution pattern
Nationwide, Italy, Canada, and Brazil
Recall initiation date
Feb 4, 2013
Initial firm notification
Letter
Center classification date
Feb 25, 2013

How we source this data

Source: U.S. Food and Drug Administration enforcement report F-1008-2013, published Mar 6, 2013. View the source record (openFDA) · FDA enforcement reports

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

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