The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Food)·F-1352-2014·Announced 2014-01-08

Kirkman Phenol Assist Recalled for Potential Chloramphenicol Contamination

Kirkman Group Inc. is recalling Phenol Assist dietary supplements because the raw material may contain chloramphenicol levels exceeding 0.3 ppb.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Kirkman Group Inc. is voluntarily recalling Phenol Assist, Item # 0835-090, a dietary supplement. The recall is being conducted because the product contains a raw material that may contain chloramphenicol at levels greater than 0.3 ppb.

The recall affects 1,774 bottles of the product, with 1,313 bottles distributed in the United States and 461 bottles distributed outside the United States. The affected lot numbers are 52640015, 53855003, and 53855004.

Consumers who have purchased this product should stop using it and contact the manufacturer for further instructions or a refund. The FDA has classified this recall as Class II, indicating that use of the product could cause temporary or medically reversible health consequences.

The recalled product

Product
Phenol Assist, Kirkman brand, Item # 0835-090
Manufacturer
Kirkman Group Inc.

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 numbers: 52640015
  • 53855003
  • 53855004.

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 7 recalled by Kirkman Group 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 7 products in this recall →

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