Agency classClass IIIOur severity:Low FDA (Food)·F-1013-2016·Announced 2016-04-13

Immuno-Dynamics Recalls Colostrum Powder for Incorrect Allergen Labeling

Immuno-Dynamics, Inc. is recalling PerCoBa and Synertek colostrum powder because the labels state 'contains dairy' instead of 'contains milk.'

The agency’s classification

FDA (Food): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.

Plain-English summary

Immuno-Dynamics, Inc. is voluntarily recalling PerCoBa Extra Edge and Synertek Balanced Pure colostrum powder dietary supplements. The recall is due to a labeling error where the products state 'contains dairy' rather than the required 'contains milk.'

The affected products include 150-gram and 250-gram jars of PerCoBa Extra Edge and 8.8-ounce jars of Synertek Balanced Pure. These products were distributed nationwide, including Puerto Rico, and to various countries outside the United States.

Consumers with milk allergies should avoid using these products. The FDA classifies this recall as Class III, indicating that there is a reasonable probability that the use of or exposure to the violative product will not cause adverse health consequences.

The recalled product

Product: Colostrum Powder, Dietary Supplement, Allergen statement: contains dairy. Colostrum (bovine) packaged in the following sizes and brand names: 1. PerCoBa Extra Edge Net Weight 150 grams, UPC 90576-00099. 3,000 mg Colostrum (bovine) per 2 teaspoons. Immuno-Dynamics, Inc.…
Manufacturer: Immuno - Dynamics, Inc
Category: Food — Dietary Supplement
Hazard: allergen-milk
mis-labeling

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 (20)

250 gram jar Lots: 627-30
628-30
628-31
630-31
632-30
633-30
633-31
635-30
635-35
636-30
637-30
637-31
638-30
638-31
639-30
639-31
639-32
641-30
642-30
644-30

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 5 recalled by Immuno - Dynamics, Inc under a single FDA (Food) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

Same manufacturer · Immuno - Dynamics, Inc

See all →

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PerCoBa Whey Protein Isolate Recalled for Missing Milk Allergen Labeling
FDA (Food) · 2016-04-13
High
Immuno-Dynamics Recalls PerCoBa Colostrum Supplement for Missing Milk Labeling
FDA (Food) · 2016-04-13
Moderate
PerCoBa Colostrum Capsules Recalled for Incorrect Milk Allergen Labeling
FDA (Food) · 2016-04-13
Moderate
Immuno-Dynamics Recalls Colostrum Lozenges for Allergen Labeling Error
FDA (Food) · 2016-04-13

Same hazard · allergen milk