FDA recall record

Professional Complementary Health Formulas 60-count dissolvable tablet in white plastic recall — FDA F-3348-2017

Sublinqual B12 tablets are recalled because the ingredients statement declared lactose but label does not declare milk.

Class IIclassification
F-3348-2017official record ID
Aug 9, 2017report date

Recall record at a glance

Official recordF-3348-2017
CategoryFood Recalls
ClassificationClass II
FDA record statusTerminated
Recalling firmProfessional Complementary Health Formulas, LLC
Report dateAug 9, 2017
Recall initiation dateJul 21, 2017
Quantity2178/60 tablets Bottles
LocationLake Oswego, OR, United States

Official product description

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.

Why the product was recalled

Sublinqual B12 tablets are recalled because the ingredients statement declared lactose but label does not declare milk.

Distribution information

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

How to read the classification

FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.

Additional record details

Recall type: Voluntary: Firm initiated. Initial notification: Letter.

What to do next

If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.

About this record

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