SourceCF(R) Pediatric Drops, Multivitamins with A, B, D, E and K Plus Zinc, 2 FL OZ.
Aptalis Pharma Us Inc recalled this product and the FDA reported the enforcement action on 6 March 2013 as Class II. The recall was initiated by the firm. The data suggests that the formulation does not support the shelf life of the product as labeled.
The record
Every field below is published by the FDA in the openFDA food enforcement database. Check the FDA notice before acting on any recall: this page is a reading of the public record, not a substitute for it.
- Product
- SourceCF(R) Pediatric Drops, Multivitamins with A, B, D, E and K Plus Zinc, 2 FL OZ. (60ML), NDC 66212-300-60, UPC 668212300600
- UPC
- 668212300600
- Reason for recall
- The data suggests that the formulation does not support the shelf life of the product as labeled.
- Recalling firm
- Aptalis Pharma Us Inc
- Firm location
- Birmingham, Alabama, United States
- Classification
- Class II
- Status
- Terminated
- Recall number
- F-1008-2013
- Quantity
- 14439 units
- Distribution
- Nationwide, Italy, Canada, and Brazil
- Initiated
- 4 February 2013
- Reported by FDA
- 6 March 2013
- Terminated
- 22 July 2013
- Firm notified by
- Letter
- Product codes
- 1BA67, exp Mar 13; 1DC02, exp Jun 13; 2BA86, exp Apr 14; 2FA92, exp Aug13.
Reading this record
Five things about this record are not in the record itself, and each one changes how it should be read.
- Class II means the FDA judged a remote probability of serious harm, or a probability of temporary or medically reversible harm. The class is assigned by an agency health hazard evaluation under 21 CFR 7.41, not by the firm.
- The firm started this recall itself. Most FDA food recalls are voluntary, and a recall is a food safety plan working rather than failing. The circumstances in which the agency asks for one instead are set out in 21 CFR 7.45.
- This record is the only one the FDA opened for its recall event, so it covers a single product code.
- The recall ran for 6 months, from 4 February 2013 to termination on 22 July 2013. Termination means the agency judged that all reasonable effort had been made, under 21 CFR 7.55, and it says nothing about whether product remained in circulation.
- The FDA published the enforcement report 4 weeks after the firm began the recall.
- Recalls of a dietary supplement run a median of 15 months, so this one was shorter than usual for its category. Dietary supplements are regulated under their own good manufacturing practice rule, 21 CFR part 111, and they are the only food category where the dominant recall reason is an ingredient that was never declared because it is a pharmaceutical.
Filed under dietary supplements. A product can sit in more than one.
Other dietary supplements recalls
These are the closest records in the corpus: the same kind of food. Unlike the firm’s own records below, they come from different companies, which is what makes them a pattern rather than a history.
All 2013 recalls · All FDA food recall data
Behind every recall is a clause somebody has to produce evidence for at their next audit. Krolda maps supplier documents to the clause they satisfy in FSSC 22000, IFS Food and 21 CFR 117, and routes the corrective action when the evidence is missing.
Early accessRecall records come from the openFDA food enforcement API, published by the U.S. Food and Drug Administration in the public domain. Krolda adds the hazard classification and the clause mapping; neither is an FDA determination. Always check the FDA notice before acting on a recall.