The Recall Desk
Agency classClass IIOur severity:SevereFDA (Food)·F-1127-2013·Announced 2013-03-27

Pascalite Powder Recalled for Potential Lead Contamination

Pascalite, Incorporated is recalling Pascalite Powder products because they may contain violative levels of lead.

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, and the hazard involves lead contamination in a product intended for oral use and dietary supplementation, which aligns with the rubric criteria for Severe severity.

Plain-English summary

Pascalite, Incorporated is recalling Pascalite Powder products in 8 oz, 16 oz, 5 lb, and 25 lb semitransparent flexible plastic containers. The products are being recalled because they may contain violative levels of lead.

The affected products are labeled with directions for use as a poultice, skin cleanser and softener, deodorant and freshener, dentrifice and oral hygiene product, and dietary supplement for adults and children over 6. The recall includes part of 2,655 units distributed nationally in the U.S. and in Canada, the UK, Hong Kong, and Australia.

Consumers should stop using the product immediately. Lot numbers are imprinted or hand-written on the bottom of the product and include 2010M, and D10 through 12 with a noted OT, U, V, or W.

The recalled product

Product
Pascalite Powder 8 oz, 16 oz, 5 lb, and 25 lb packaged in semitransparent flexible plastic containers with a stick on label. Pascalite Clay Powder, Pascalite Inc, PO Box 104 Worland, WY 82401, 307-347-3872 with directions for use as a Poultice, skin cleanser and softener…
Manufacturer
Pascalite, Incorporated
Category
Food — Dietary Supplement
Hazard
Affected units
2,655

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 (5)

  • Lot numbers imprinted or hand written include: 2010M
  • and D10 through 12 with a noted OT
  • U
  • V
  • or W. The code information is found on the bottom of the product.

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 recalled by Pascalite, Incorporated 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 2 products in this recall →

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