The Recall Desk
Agency classClass IIOur severity:SevereFDA (Food)·F-1642-2014·Announced 2014-03-19

Global Vitality Recalls Super Digestayme Supplements Due to Chloramphenicol Contamination

Global Vitality is recalling Super Digestayme dietary supplements because they may be contaminated with chloramphenicol. The products were made with a raw ingredient previously recalled for the same contaminant.

The agency’s classification

FDA (Food): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 classification is FDA Class II. According to the rubric, an FDA Class II recall corresponds to a severity score of 4 (Severe), particularly given the presence of a significant chemical contaminant (chloramphenicol) in a dietary supplement.

Plain-English summary

Global Vitality, Inc. dba Enzyme Process International is recalling specific units of Super Digestayme dietary supplements. The recall involves 200-count and 300-count packages in various box configurations. The affected units are identified by Lot 1585.

The recall was initiated because the dietary supplements may be contaminated with chloramphenicol. The company states that the products were manufactured using a raw ingredient that had been previously recalled by Specialty Enzymes & Biotechnologies due to chloramphenicol contamination.

Approximately 69,800 units were distributed in Pennsylvania, Arizona, and Hawaii. Consumers who have these products should stop using them and follow the instructions provided by the recalling firm or the FDA regarding disposal or return.

The recalled product

Product
Super Digestayme, 200 count, 2 boxes x 72 bottles, 1 box x 55 bottles. 300 count, 4 boxes x 72 bottles, 1 box x 12 bottles.
Affected units
69,800

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 (1)

  • Lot 1585

Distribution

Distributed in 3 states:

Part of a larger recall action

This product is one of 9 recalled by Global Vitality, Inc. dba Enzyme Process International 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 9 products in this recall →

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