FDA Issues Class I Designation for Ice Cream Recall

FDA Issues Class I Designation for Ice Cream Recall

(RepublicanPress.org) – The Food and Drug Administration (FDA) issued a press release last month detailing a voluntary ice cream recall by Totally Cool, Inc. Media outlets reported that the massive recall involved 68 products across 13 brands, including products sold by Jeni’s, Chipwich, and Hershey’s. Lightning struck twice; another manufacturer issued a similar notice about a contaminated ice cream product.

Leana’s Ice Cream, Inc. produces “small batch ice cream sandwiches and pints” made from local ingredients. It uses a natural enzyme to produce a lactose-free dairy product. On July 1, the Wilkinsburg, Pennsylvania, manufacturing company issued a voluntary recall on its six-ounce, individually wrapped Leona’s Ice Cream Strawberry Pretzel Salad ice cream sandwiches.

The company warned that the product was cross-contaminated with peanuts, an ingredient known in some people to cause anaphylaxis, a life-threatening condition that narrows a person’s airways and can cause them to stop breathing.

On July 10, the FDA followed up by issuing a Class I notice of the voluntary recall from Leona’s Ice Cream, a Wilkinsburg, Pennsylvania company. The federal agency did not issue a press release on the product since Leona’s Ice Cream appeared to have completed the recall.

The federal agency ranks product recalls using a numerical designation to indicate the potential health risk the products present.

  • Class I: A “reasonable probability” exists that exposure to the product or its use “will cause serious adverse health consequences or death.”
  • Class II: The potential for serious illness due to exposure to, or the use of a product is “remote,” or use of the recalled item “may cause temporary or medically reversible adverse health consequences.”
  • Class III: The exposure to, or using, a product isn’t likely to cause an adverse health condition.

A review of the FDA notice indicated that Leona’s recalled 136 ice cream sandwiches. Although the agency and Leona’s Ice Cream listed cross-contamination as the reason for the recall, several news outlets and industry websites noted that the issue involved labeling and not a problem with ingredients.

The Food Industry Counsel reported that the labels for the recalled ice cream sandwiches didn’t include peanuts.

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