Pascalite Powder 8 oz, 16 oz, 5 lb, and 25 lb packaged in semitransparent flexible…
Pascalite, Incorporated recalled this product and the FDA reported the enforcement action on 27 March 2013 as Class II. The recall was initiated by the firm. Pascalite is recalling internally used pascalite powder products because they may contain violative levels of lead.
The record
Every field below is published by the FDA in the openFDA food enforcement database. Check the FDA notice before acting on any recall: this page is a reading of the public record, not a substitute for it.
- 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, deodorant an freshener, dentrifice and oral hygiene, and dietary supplement for adults and children over 6.
- Reason for recall
- Pascalite is recalling internally used pascalite powder products because they may contain violative levels of lead.
- Recalling firm
- Pascalite, Incorporated
- Firm location
- Worland, Wyoming, United States
- Classification
- Class II
- Status
- Terminated
- Recall number
- F-1127-2013
- Quantity
- In part of 2,655 units.
- Distribution
- Nationally (U.S.); Canada, UK, Hong Kong, and Australia.
- Initiated
- 2 January 2013
- Reported by FDA
- 27 March 2013
- Terminated
- 10 April 2013
- Firm notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Product codes
- 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.
Reading this record
Five things about this record are not in the record itself, and each one changes how it should be read.
- Class II means the FDA judged a remote probability of serious harm, or a probability of temporary or medically reversible harm. The class is assigned by an agency health hazard evaluation under 21 CFR 7.41, not by the firm.
- The firm started this recall itself. Most FDA food recalls are voluntary, and a recall is a food safety plan working rather than failing. The circumstances in which the agency asks for one instead are set out in 21 CFR 7.45.
- This is one of 2 records covering the same recall event. The FDA opens one enforcement record per product code, so a recall of a product line appears here many times. Counting these records as 2 separate recalls, which almost every published figure does, overstates it by a factor of 2. All 2 of them are listed on this page.
- The recall ran for 3 months, from 2 January 2013 to termination on 10 April 2013. Termination means the agency judged that all reasonable effort had been made, under 21 CFR 7.55, and it says nothing about whether product remained in circulation.
- The FDA published the enforcement report 3 months after the firm began the recall.
- Recalls of a dietary supplement run a median of 15 months, so this one was shorter than usual for its category. Dietary supplements are regulated under their own good manufacturing practice rule, 21 CFR part 111, and they are the only food category where the dominant recall reason is an ingredient that was never declared because it is a pharmaceutical.
What this recall was for
Chemical contamination
A chemical contamination recall covers a substance that is harmful in food and was never meant to be there: a heavy metal, a cleaning chemical, a pesticide residue, or a natural toxin such as aflatoxin or histamine.
A preventive controls plan covers chemical contamination under the clauses below. This is where the control belongs, not a finding against any firm named on this page: a recall record states a reason, and most of these recalls were initiated by the firm itself.
- 21 CFR 117.35(b)
- Substances used in cleaning and sanitizing: toxic materials stored, identified and used so they cannot contaminate food, food-contact surfaces or packaging.
- 21 CFR 117 subpart G
- Supply-chain programme: the approval and verification a receiving facility runs on a supplier when the hazard is controlled before the ingredient arrives.
- 21 CFR 117.130(b)(1)(ii)
- Hazard analysis: identifying the known or reasonably foreseeable chemical hazards, including radiological hazards, pesticide and drug residues, natural toxins and food decomposition.
Filed under dietary supplements. A product can sit in more than one.
Every product in this recall
The FDA opened 2 enforcement records for this one recall, one per product code. This page carries all of them; the 1 below each have their own page with that product’s lot codes and distribution, and search engines are pointed here for the recall as a whole.
| Reported | Product | Firm | Reason | Class |
|---|---|---|---|---|
| 2013-03-27 | Pascalite Capsules 100 count white plastic bottle with a screw on top, Pascalite Inc, PO Box 104 Worland, WY 82401 307-347-3872, Dietary Supplement for adults and children over 12 years two capsules daily, each vegi cap (size 00) contains approx. 1/4 tsp pascalite powder. | Pascalite, Incorporated | Pascalite is recalling internally used pascalite powder products because they may contain violative levels of lead. | Class II |
Other dietary supplements recalls for the same reason
These are the closest records in the corpus: the same kind of food, recalled for a hazard this record also names. Unlike the firm’s own records below, they come from different companies, which is what makes them a pattern rather than a history.
Other records from Pascalite, Incorporated
The FDA opens one enforcement record per product code, so several of these are frequently one recall event.
| Reported | Product | Firm | Reason | Class |
|---|---|---|---|---|
| 2013-03-27 | Pascalite Capsules 100 count white plastic bottle with a screw on top, Pascalite Inc, PO Box 104 Worland, WY 82401 307-347-3872, Dietary Supplement for adults and children over 12 years two capsules daily, each vegi cap (size 00) contains approx. 1/4 tsp pascalite powder. | Pascalite, Incorporated | Pascalite is recalling internally used pascalite powder products because they may contain violative levels of lead. | Class II |
All 2013 recalls · All FDA food recall data
21 CFR 117.35(b) is the clause behind this recall, and it is one somebody has to produce evidence for at their next audit. Krolda maps supplier documents to the clause they satisfy in FSSC 22000, IFS Food and 21 CFR 117, and routes the corrective action when the evidence is missing.
Early accessRecall records come from the openFDA food enforcement API, published by the U.S. Food and Drug Administration in the public domain. Krolda adds the hazard classification and the clause mapping; neither is an FDA determination. Always check the FDA notice before acting on a recall.