FDA gives Abbott green light to ship some products

The FDA has advised Abbott Nutrition that it can ship certain of its products, which have been on hold pending the completion of the agency’s investigation into an outbreak of Cronobacter sakazakii infections linked to Abbott’s powdered infant formula products.

The company announced a recall of multiple Similac, Alimentum and EleCare products on February 17, 2022.

The decision to allow release of certain products is contingent on Abbott’s committing to  completing enhanced testing of stored product batches prior to making release determinations on a case-by-case basis.

In announcing its decision, the FDA explained that it 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. 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.”

The following Specialty and Metabolic Formulas may be Released on a Case-By-Case Basis:

  • Glutarex-1
  • Glutarex-2
  • Cyclinex-1
  • Cyclinex-2
  • Hominex-1
  • Hominex-2
  • I-Valex-1
  • I-Valex-2
  • Ketonex-1
  • Ketonex-2
  • Phenex-1
  • Phenex-2
  • Phenex-2 Vanilla
  • Pro-Phree
  • Propimex-1
  • Propimex-2
  • ProViMin
  • Calcilo XD
  • Tyrex-1
  • Tyrex-2
  • Similac PM 60/40

The products eligible for possible release were placed on hold at the company’s Sturgis, Michigan facility, but were not included among the list of recalled products.

These specialty products are sold through specialty pharmacies and other specialty distribution channels such as medical product suppliers, and often require a prescription.

Learn more about Cronobacter sakazakii and other foodborne disease outbreaks in TAINTED. From Farm Gate to Dinner Plate, Fifty Years of Food Safety Failures, now available in digital, print and audiobook editions.

TAINTED formats 3
“Reads like a true crime novel” – Food Safety News

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