The Recall Desk
Agency classClass IIOur severity:SevereFDA (Food)·F-1636-2014·Announced 2014-03-19

Global Vitality Recalls Fat Sugar Dietary Supplements Due to Chloramphenicol Contamination

Global Vitality is recalling bulk Fat Sugar dietary supplements because they may be contaminated with chloramphenicol. The product was 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 recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric. The presence of chloramphenicol, a prohibited antibiotic, represents a significant health risk.

Plain-English summary

Global Vitality, Inc. dba Enzyme Process International is recalling bulk Fat Sugar dietary supplements because they may be contaminated with chloramphenicol. The recalled product consists of 3 boxes of 12 kg and 1 box of 8.76 kg, identified as Lot 1845. The total quantity involved is 100,000 units.

The recall was initiated because the dietary supplements were manufactured using a raw ingredient that had been previously recalled by Specialty Enzymes & Biotechnologies due to chloramphenicol contamination. Chloramphenicol is an antibiotic that is not permitted in dietary supplements.

The affected product was distributed in Pennsylvania (PA), Arizona (AZ), and Hawaii (HI). Consumers who have purchased this product should stop using it and contact the recalling firm for instructions on how to return the product or obtain a refund.

The recalled product

Product
Fat Sugar (bulk), 3 boxes x 12 kg, 1 box x 8.76 kg.
Affected units
100,000

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 1845

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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