FDA recall record

Aptalis Pharma Us SourceCF recall — FDA F-1008-2013

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

Class IIclassification
F-1008-2013official record ID
Mar 6, 2013report date

Recall record at a glance

Official recordF-1008-2013
CategoryFood Recalls
ClassificationClass II
FDA record statusTerminated
Recalling firmAptalis Pharma Us Inc.
Report dateMar 6, 2013
Recall initiation dateFeb 4, 2013
Quantity14439 units
LocationBirmingham, AL, United States

Official 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

Why the product was recalled

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

Distribution information

Nationwide, Italy, Canada, and Brazil

How to read the classification

FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.

Additional record details

Recall type: Voluntary: Firm initiated. Initial notification: Letter.

What to do next

If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.

About this record

Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.

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