#822- M PrimarqueClam Base, Net Weight 50 Pounds (22.68 kg) Packed for Primarque…

Williams West & Witt's Products Company recalled this product and the FDA reported the enforcement action on 26 December 2012 as Class II. The recall was initiated by the firm. The ingredient label did not identify the source of butter and cream ingredient as milk, an allergen. Consumers with a milk allergy run the risk of serious or life-threatening allergic reaction if they consume these products.

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

#822- M PrimarqueClam Base, Net Weight 50 Pounds (22.68 kg) Packed for Primarque Products, Worcester, MA 01610

Reason for recall

The ingredient label did not identify the source of butter and cream ingredient as milk, an allergen. Consumers with a milk allergy run the risk of serious or life-threatening allergic reaction if they consume these products.

Recalling firm

Williams West & Witt's Products Company

Firm location

Michigan City, Indiana, United States

Classification

Class II

Status

Terminated

Recall number

F-0838-2013

Quantity

850 lbs.

Distribution

USA including IN, IL, KY, MA, NY, WI

Initiated

28 November 2012

Reported by FDA

26 December 2012

Terminated

15 February 2013

Firm notified by

Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Product codes

Lot 141208E, 161211D

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 13 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 13 separate recalls, which almost every published figure does, overstates it by a factor of 13. Every product code in this event is listed together on the record that covers the whole recall, which is the page a search engine is pointed to for all 13 of them.
• The recall ran for 3 months, from 28 November 2012 to termination on 15 February 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 distribution pattern names 5 states, and the FDA published the enforcement report 4 weeks after the firm began the recall.
• The product description on this record names no food this site can classify, so it appears on no food-type page. That is a limit of the description rather than of the recall.

Named in the distribution pattern: Illinois, Kentucky, Massachusetts, New York, Wisconsin. Those pages count recalls by where the RECALLING FIRM sits, which is a different question from where this product went.

Other records from Williams West & Witt's Products Company

The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 12 other records name this firm.

All 13 records for Williams West & Witt's Products Company

All 2012 recalls · All FDA food recall data