Food recall

Professional Complementary Health Formulas, LLC recall: Professional Formulas Sublinqual B12 High-Potency dietary supplement

Professional Complementary Health Formulas, LLC, of Lake Oswego, OR, recalled Professional Formulas Sublinqual B12 High-Potency dietary supplement. The FDA's reason: “Sublinqual B12 tablets are recalled because the ingredients statement declared lactose but label does not declare milk.” The FDA classified it Class II: it could cause temporary or minor harm. The company began the recall voluntarily on July 21, 2017, and the FDA first listed it in its Enforcement Report of August 9, 2017. The FDA has closed the recall: it found the company did all it reasonably could to remove or correct the product.

How serious

Class II

It could cause temporary or minor harm

Why

Allergen not on the label

Status

Terminated

Closed March 21, 2018

The recall

Company
Professional Complementary Health Formulas, LLC (Lake Oswego, OR)
Reason, in FDA's words
“Sublinqual B12 tablets are recalled because the ingredients statement declared lactose but label does not declare milk.”
Where it was sold
distributed in AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, LA, MA, MD, ME, MI, MT, NC, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, WA, and WI and in the following countries: Canada and United Kingdom
Recall began
, by the company
FDA classified it
First in an FDA Enforcement Report
FDA event number
77806

The product recalled

As the FDA describes them, with the codes that tell whether a package is part of the recall.

  • F-3348-2017 Class II

    Professional Formulas Sublinqual B12 High-Potency dietary supplement, 60-count dissolvable tablet in white plastic bottles. Adhesive label with White, black red and green print; bottle has a heat-shrink band. UPC code 8 40851 10054 0.

    Codes: Lot numbers: 409017; 503019; 508060; 603032; and 701039. QR Codes: 1409002; 1505019; 1603007; 1607022; and 1701013. QR codes are interpreted as below: " The first two digits represent the year in which the product was ordered or manufactured; " The second two digits represent the month in which the product was ordered or manufactured; and " The last three digits represent the products place in a sequential list of products ordered during that month and year.

    Quantity: 2178/60 tablets Bottles

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Source and notes

U.S. Food and Drug Administration, Enforcement Reports (openFDA food recall data) (Public domain (U.S. government work); source U.S. Food and Drug Administration, openFDA), data as of August 9, 2017.

Each week the FDA lists the recalls it has classified in its Enforcement Report, often weeks after the company announced the recall, so a month with five weekly reports tends to count more. Each recall counts once, however many products it covers, in the month FDA first listed it. Class I means the food could cause serious harm or death, Class II temporary or minor harm, and Class III is unlikely to harm anyone. Meat, poultry and most egg products are recalled by the U.S. Department of Agriculture, not the FDA, and aren't included. For what to do with a recalled product, see the FDA's recalls page.