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Professional Complementary Health Formulas, LLC Recall: Sublinqual B12 tablets are recalled because the ingredients statement declared lactose but label does not declare milk.

United States

TerminatedClass II

Company
Professional Complementary Health Formulas, LLC
Product
Professional Formulas Sublinqual B12 High-Potency dietary su…
Recall date
July 21, 2017
Terminated
March 21, 2018
Source
FDA

Reason for recall

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

  1. - Recall initiated
  2. - Reported by source
  3. - Recall terminated
Recalled products
Product description UPC Quantity Lot / code information
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. Not published in this source record 2178/60 tablets Bottles 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.

Distribution

  • 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

Official source record

Agency
FDA
Dataset
FDA Food Enforcement (Recalls)
Recall number
F-3348-2017
Event ID
77806
Status
Terminated
Classification
Class II
Company
Professional Complementary Health Formulas, LLC
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.
Quantity
2178/60 tablets Bottles
Reason
Sublinqual B12 tablets are recalled because the ingredients statement declared lactose but label does not declare milk.
Recall initiation date
July 21, 2017
Report date
August 9, 2017
Classification date
Not published in this source record
Termination date
March 21, 2018
Distribution pattern
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
UPC, lot, and code information
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.
Voluntary or mandated
Voluntary: Firm initiated
Initial notification method
Letter
Source last updated
Not tracked separately from the Public Health Trace retrieval date below
Public Health Trace retrieval date

Responsible company: Professional Complementary Health Formulas, LLC

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Distribution map

A map highlighting the states named in the source's distribution description.

Shading reflects state-level totals only, as published by the source. It does not imply county-level or point-level precision.

Distribution map
State Distributed
Arizona 1
California 1
Colorado 1
Connecticut 1
Florida 1
Georgia 1
Hawaii 1
Idaho 1
Illinois 1
Indiana 1
Kansas 1
Louisiana 1
Massachusetts 1
Maryland 1
Maine 1
Michigan 1
Montana 1
North Carolina 1
New Jersey 1
New Mexico 1
Nevada 1
New York 1
Ohio 1
Oklahoma 1
Oregon 1
Pennsylvania 1
Rhode Island 1
South Carolina 1
South Dakota 1
Tennessee 1
Texas 1
Utah 1
Washington 1
Wisconsin 1

States shown are extracted from the source's free-text distribution description above; a narrative description (e.g. "distributed nationwide") may not list individual states to extract.

Where this information comes from

View FDA enforcement record -- the specific openFDA record this summary was built from.

No separate FDA public notice was found for this enforcement record. The information below comes from FDA's Recall Enterprise System through openFDA.

FDA Enforcement Reports -- FDA's general, official recall and enforcement information.

Technical source data

View raw source data -- the machine-readable record this page's information was built from.

Retrieved by Public Health Trace:

Frequently asked questions

What does a Class II mean?

A situation in which use of or exposure to a product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote.

Is this recall still active?

According to FDA, this recall's status is "Terminated." Always confirm the current status using the source links below, since status can change after Public Health Trace last retrieved this record.

What should I do if I have this product?

Follow the instructions published by the responsible agency (see the source links below) -- recall guidance (e.g. dispose of the product, return it for a refund, or check for a specific lot number) varies by recall and is set by that agency, not by Public Health Trace.

Where can I find more official information?

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