The Recall Desk
Agency classClass IOur severity:SevereFDA (Food)·F-0332-2016·Announced 2015-12-09

Dietary Supplement Recalled for Undeclared Milk and Shellfish Allergens

VRVK Nutraceuticals is recalling Dr. Venessa's Formulas Ultimate Antioxidant Tablets because FDA inspection found undeclared milk and crustacean shellfish.

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 dietary supplement contains undeclared milk and crustacean shellfish based on FDA's inspection."

Plain-English summary

VRVK Nutraceuticals, LLC is recalling 3,554 bottles of Dr. Venessa's Formulas Ultimate Antioxidant Tablets dietary supplement. The product is sold in 120-count bottles with UPC 606851551205. The recall covers Lot Number 132415 (expiration date 05/16) and Lot Number 141381 (expiration date 06/17).

The recall was initiated because FDA inspection determined that the dietary supplement contains undeclared milk and crustacean shellfish. These are major food allergens that are not listed on the product label.

The affected product was distributed nationwide and in Puerto Rico. Consumers with these products should stop using them and contact the recalling firm for instructions on disposal or return.

The recalled product

Product
DR. VENESSA'S FORMULAS ULTIMATE ANTIOXIDANT TABLETS DIETARY SUPPLEMENT, 120 count bottles, UPC 606851551205
Affected units
3,554

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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