 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
The FDA is providing information to health care professionals to help their patients obtain access to medically necessary specialty, amino acid-based and metabolic infant formula products.
The FDA is continuing to work to ensure infants and individuals with medical conditions who rely on certain specialty, amino acid-based and metabolic infant formula products have access to these life-sustaining products since Abbott Nutrition voluntarily recalled certain infant formula products on Feb. 17. Some of these products have been available on a case-by-case basis from Abbott Nutrition over the last several months because the risk of not having access to them could significantly worsen underlying medical conditions and in some cases pose life-threatening risks.
To date, this case-by-case release has provided life-sustaining products to 2,958 infants and individuals in need, and approximately 500,000 containers of additional product remain accessible to those in need. These products have not been impacted by a June 13 storm that flooded parts of Abbott’s Sturgis, MI facility. Products are available on a case-by-case basis to patients, hospitals, and institutions by calling Abbott Nutrition.
Contact information for Abbott and other manufacturers who produce specialty and metabolic formulas is below. Health care professionals may contact manufacturers for information or assistance to obtain products.
Abbott Nutrition: 1-800-881-0876 (Alimentum, EleCare, and metabolic products)
Mead Johnson/Reckitt: 1-812-429-6399 (Nutramigen, Puramino, and metabolic products)
Nutricia: 1-800-365-7354 (Neocate and metabolic products)
Nestlé-Gerber Company:
Gerber Products Company: 1-800-284-9488 (Gerber Good Start Extensive HA Infant Formula)
Nestlé Health Science: 1-800-422-2752 (Alfamino products)
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