The Recall Desk
Agency classClass IOur severity:SevereFDA (Food)·F-1879-2013·Announced 2013-09-18

Reaction Nutrition Recalls Immune Support Supplement for Undeclared Colostrum Allergen

Reaction Nutrition LLC is recalling 600 bottles of Clinical LIVE Immune Support capsules because they contain undeclared colostrum, a dairy allergen.

The agency’s classification

FDA (Food): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "The product contained an undeclared allergen, Colostrum, which is considered a dairy product and therefore requires an allergen statement on the label."

Plain-English summary

Reaction Nutrition LLC is recalling 600 bottles of Clinical LIVE Dietary Supplement Immune Support 694.325 mg 90 capsules. The product is distributed by Reaction Nutrition, LLC., located in Carnegie, PA. The recall involves lot # PB0091512 with an expiration date of 8/2014 and UPC code 283333900111.

The recall was initiated because the product contains an undeclared allergen, colostrum. Colostrum is considered a dairy product and requires an allergen statement on the label. The product was distributed nationwide.

Consumers with a dairy allergy or sensitivity should not consume this product. Individuals who have already consumed the product and experience adverse reactions should seek medical attention. Consumers can contact the recalling firm for more information or to return the product.

The recalled product

Product
Clinical LIVE Dietary Supplement Immune Support 694.325 mg 90 capsules Distributed by Reaction Nutrition, LLC., Carnegie, PA.
Affected units
600

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • lot # PB0091512
  • exp. date 8/2014
  • UPC code 283333900111

Distribution

Distributed nationwide across the United States.

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