Aptalis Recalls SourceCF Pediatric Multivitamin Drops Due to Shelf Life Concerns
Aptalis Pharma is recalling SourceCF Pediatric Drops because the formulation may not support the labeled shelf life. The recall covers 14,439 units distributed in the US, Italy, Canada, and Brazil.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically involves a situation that could cause temporary or medically reversible health consequences. The hazard is related to shelf-life stability rather than an acute contamination or injury risk, fitting the Moderate category for low-risk contamination or labeling/stability issues.
Plain-English summary
Aptalis Pharma Us Inc is recalling SourceCF(R) Pediatric Drops, Multivitamins with A, B, D, E and K Plus Zinc, 2 FL OZ. (60ML). The recall involves 14,439 units of the product, which is identified by NDC 66212-300-60 and UPC 668212300600.
The recall was initiated because data suggests that the product's formulation does not support the shelf life as labeled. This indicates a potential stability issue where the product may not remain effective or safe for the duration stated on the packaging.
The affected lots are 1BA67 (exp Mar 13), 1DC02 (exp Jun 13), 2BA86 (exp Apr 14), and 2FA92 (exp Aug 13). The product was distributed nationwide in the United States, as well as in Italy, Canada, and Brazil. Consumers should check their inventory for these specific lot numbers and expiration dates. If they possess the recalled product, they should stop using it and contact the recalling firm or their healthcare provider for further instructions.
The recalled product
- 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
- Manufacturer
- Aptalis Pharma Us Inc
- Category
- Drug — Multivitamins
- Hazard
- Affected units
- 14,439
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 (8)
- 1BA67
- exp Mar 13
- 1DC02
- exp Jun 13
- 2BA86
- exp Apr 14
- 2FA92
- exp Aug13.
Distribution
Distributed nationwide across the United States.
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