The Recall Desk
Agency classClass IIOur severity:SevereFDA (Food)·F-0089-2014·Announced 2013-11-13

American Laboratories Recalls Pectinase Enzyme Powder Due to Chloramphenicol Contamination

American Laboratories Inc is recalling Pectinase 3,500 ENDO-PG/G enzyme powder due to potential chloramphenicol contamination. The product was distributed to Iowa, Utah, Nevada, Nebraska, and California.

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, which corresponds to a Severe rating under the rubric, particularly given the presence of a significant chemical contaminant.

Plain-English summary

American Laboratories Inc is recalling one sample bottle (100 gm) of Pectinase 3,500 ENDO-PG/G, powder, enzyme, Product 70A. The recall is due to the potential for the product to be contaminated with chloramphenicol.

The affected product, identified by Lot ALI13157-09 with a re-evaluation date of 12/6/2014, was distributed to Iowa, Utah, Nevada, Nebraska, and California. The source text notes that the item is a sample and was not tested.

Consumers who possess this specific lot of the enzyme powder should stop using it and contact the recalling firm for further instructions.

The recalled product

Product
Pectinase 3,500 ENDO-PG/G, powder, enzyme, 100 gm. Product 70A
Affected units
100

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 ALI13157-09
  • Yellow
  • Red and Orange.The spreadsheet

Distribution

Distributed in 5 states:

Part of a larger recall action

This product is one of 9 recalled by American Laboratories 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 9 products in this recall →

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