Abbott To Release Infant Formula On Case-By-Case Basis Following Massive Recall

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Abbott Infant Formula Investigation Release Overview: 

• Who: The U.S. Food & Drug Administration (FDA) said it will allow Abbott to start distributing some of its infant formulas again after multiple products were recalled due to potential contamination.
• Why: The FDA said it was concerned not having the products on the market could put babies who rely on the products at risk. 
• Where: The products will be released in the United States.

Abbott Nutrition will be allowed to start distributing some of its infant formulas again even though the products are under investigation after several babies were sickened. 

On Apr. 29, the U.S. Food & Drug Administration (FDA) said it “has no objection” to Abbott immediately releasing products to “individuals needing urgent, life-sustaining supplies” of certain specialty formulas on a case-by-case basis, CNN reported. 

The FDA and the U.S. Centers for Disease Control and Prevention are currently investigating Abbott Nutrition’s powdered infant formula products after the formula was linked to a rash of infant illnesses and potentially two infant deaths. 

So far, the agencies have said the baby formula maker did not maintain sanitary conditions at the Michigan manufacturing plant where it produced the baby formula.

Abbott has recalled Similac, Alimentum and EleCare products produced at its Sturgis facility while enhanced safety testing is conducted. However, the formula recalls have exacerbated baby formula product shortages due to supply chain issues. 

Some of the recalled formulas were specialty mixes for babies in need, which are not readily available from other brands. 

Parents Can Contact Abbott for Specialty, Metabolic Infant Formulas, FDA Says

As its investigation will take time, the FDA said certain specialty and metabolic formulas could be released by Abbott on a case-by-case basis.

“The FDA is concerned that the risk of not having certain specialty and metabolic products available could significantly worsen underlying medical conditions and in some cases pose life-threatening risks for infants and individuals who rely on these products,” the agency said. “In these circumstances, the benefit of allowing parents, in consultation with their healthcare providers, to access these products may outweigh the potential risk of bacterial infection.”

Abbott told CNN it would be releasing limited quantities of metabolic nutrition formulas that were previously on hold at the request of FDA.

“The products have been tested and comply with all product release requirements before distribution,” the FDA said. “The lots being released were not included in the recall.”

Parents seeking the product should contact Abbott directly to request it, the FDA said. 

The company said products will be released free to patients in coordination with healthcare professionals.

Were you affected by this recall? See if you can join a baby formula side effects lawsuit investigation (links to paid attorney advertising). 

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