FDA to allow Abbott to release product to individuals needing urgent, life-sustaining supplies of the specialty and metabolic formulas

How confident should we feel with this waring from the FDA:

“those seeking access [to the formula] should consult with their healthcare provider in considering whether the benefit of consuming such product outweighs the potential risk of bacterial infection in the user’s particular circumstances.”

Linked to Cronobacter sakazakii to date:

Illnesses: 4

Deaths: 2

States: 3 (Minnesota, Ohio, Texas)

The U.S. Food and Drug Administration (FDA), along with the Centers for Disease Control and Prevention (CDC) and state and local partners are investigating consumer complaints and/or reports of infant illness, received from 9/20/2021 to 1/11/2022, related to products from Abbott Nutrition’s Sturgis, MI, facility. The four ill patients are reported to have consumed powdered infant formula produced from Abbott Nutrition’s Sturgis, MI, facility.

Following the voluntary recall and hold of certain powdered infant formula products produced at the Abbott Nutrition facility in Sturgis, MI, Abbott has committed to completing enhanced testing of stored product batches prior to making release determinations. While the FDA recognizes that Abbott has conducted standard product testing, there were a limited number of samples tested. Additionally, although finished product testing does not eliminate the risk of contamination, the enhanced testing will provide for a greater chance to detect Cronobacter sakazakii, if present; however, this enhanced level of testing will take additional time.

In the meantime, the FDA has informed Abbott Nutrition that the agency has no objection to the company immediately releasing product to individuals needing urgent, life-sustaining supplies of the specialty and metabolic formulas listed below 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. 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 has confirmed with the FDA that the company will consider release of these products on a case-by-case basis, depending on product availability and the severity of the individual’s need. Patients and caregivers seeking access to these products should contact Abbott directly to request that a product be made available to them by calling 1-800-881-0876.

It is important for parents and caregivers to understand that any products released on a case-by-case basis at this time were made at Abbott Nutrition’s Sturgis, MI, facility, and that the processes, procedures, and conditions that the FDA observed during its inspection of the Sturgis MI production facility from January 31 – March 3, 2022, raise concerns that powdered infant formula produced at this facility prior to the FDA’s inspection carry a risk of contamination. Therefore, those seeking access should consult with their healthcare provider in considering whether the benefit of consuming such product outweighs the potential risk of bacterial infection in the user’s particular circumstances. Parents and caregivers should continue to work with their medical provider to consider whether comparable alternative products may be appropriate.

Parents and caregivers who obtain these products should carefully follow Abbott’s preparation instructions as indicated on the product container. Should product released on a case-by-case basis be used, parents and caregiver should pay close attention to the user’s health status and alert a healthcare provider immediately of any change in health status. In the meantime, the FDA is continuing to work diligently to ensure the safe resumption of production of infant formula at Abbott Nutrition’s Sturgis, Michigan facility.

Specialty and Metabolic Formulas that 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 FDA is advising consumers not to use recalled Similac, Alimentum, or EleCare powdered infant formulas. Recalled products can be identified by the 7 to 9 digit code and expiration date on the bottom of the package (see image below). Products are included in the recall if they have all three items below:

the first two digits of the code are 22 through 37 and
the code on the container contains K8, SH, or Z2, and
the expiration date is 4-1-2022 (APR 2022) or later.

In addition to products described above, Abbott Nutrition has recalled Similac PM 60/40 with a lot code 27032K80 (can) / 27032K800 (case). At this time, Similac PM 60/40 with lot code 27032K80 (can) / 27032K800 (case) is the only type and lot of this specialty formula being recalled. Additional recall information for the initial recall is available on the FDA website. Parents can also enter their product lot code on the company’s websiteExternal Link Disclaimer to check if it is part of the recall.

Republished with permission from Bill Marler and Marler Clark. Copyright (c) Marler Clark LLP, PS. All rights reserved.