Jamp-Glucose 50 and Jamp-Glucose 75 – Risk of False Negative Oral Glucose Challenge or Tolerance Test Results

Starting date:
June 7, 2018
Posting date:
June 7, 2018
Type of communication:
Dear Healthcare Professional Letter
Subcategory:
Natural health products
Source of recall:
Health Canada
Issue:
Important Safety Information
Audience:
Healthcare Professionals, Hospitals
Identification number:
RA-67008

Audience

Hospital Chiefs of Staff, healthcare professionals who use these products including endocrinologists, obstetricians and gynaecologists, family physicians, pharmacists, nurses and laboratory technicians

Key Messages

  • Jamp Pharma Corporation in consultation with Health Canada has voluntarily recalled six (6) lots of Jamp-Glucose 50 and Jamp-Glucose 75 (see Products Affected, below) because they contain less glucose than is shown on their labels which could lead to false negative results.
  • In pregnant women, false negative results can lead to a failure to diagnose gestational diabetes. For people who are not pregnant, a false negative result may lead to the delayed diagnosis and treatment of diabetes.
  • Health professionals are advised to:
    • Immediately stop using the affected lots and return them to the wholesalers as outlined in the Recall Notice issued by Jamp Pharma Corporation.
    • Contact the patients who had negative oral glucose challenge or tolerance test results involving the affected lots, and consider repeat testing, or use an alternate diagnostic test for diabetes as appropriate.

   

Issue

Jamp Pharma Corporation has voluntarily recalled three (3) lots of Jamp-Glucose 50 and three (3) lots of Jamp-Glucose 75 because they contain significantly less D-glucose than what is declard on the label. When these affected products are used, they can give false negative results and lead to a failure to diagnose diabetes. Unidentified diabetes in pregnancy can have serious consequences for the mother and the growing fetus. A false negative result in people who are not pregnant may lead to the delayed diagnosis and treatment of diabetes.

Products affected

Product Name NPN Lot Expiry Date of Distribution
Jamp-Glucose 50 80046733 1708012 2019-02 2017-11-30 to 2018-04-20
1707002 2018-12 2017-07-24 to 2018-02-26
1703001 2018-08 2017-03-02 to 2017-07-24
Jamp-Glucose 75 80046741 1711034 2019-05 2018-02-13 to 2018-04-20
1707001 2018-12 2017-08-23 to 2018-02-09
1703002 2018-08 2017-04-07 to 2017-08-24

Background information

Jamp-Glucose 50 and Jamp-Glucose 75 are natural health products containing D-glucose. They are used as part of oral glucose challenge and tolerance tests for the screening and diagnosis of diabetes, respectively. 

The affected lots have been recalled because the level of D-glucose they contain is up to nearly five times lower than what is declared on the label (i.e., lot 1708012: 11 g / 300 mL instead of 45-55g / 300 mL; lot 1711034: 16 g / 300 mL instead of 67.5-82.5 g / 300 mL). The cause of the lower D-glucose level in these lots is under investigation.

A common approach to screening for gestational diabetes in pregnant women is the use of a 50 g glucose challenge test in the late second trimester, followed by a 75 g oral glucose tolerance test if the 50 g glucose challenge is positive. False negative oral glucose test results in pregnant women may lead to a failure to diagnose gestational diabetes. Gestational diabetes can have serious clinical consequences including preeclampsia, macrosomia, and other neonatal morbidities.

Who is affected

Information for consumers

Jamp-Glucose 50 and Jamp-Glucose 75 are natural health products. They are used as part of oral glucose tests for screening and diagnosis of diabetes.

Some lots of these products have been removed from the market because they can contain lower levels of glucose than is shown on their labels. As a result, the screening test may say that you do not have diabetes when, in fact, you do.

Patients should contact their healthcare professional if they have any questions or concerns.

Information for healthcare professionals

Healthcare professionals should immediately stop using the affected lots and return them to the wholesalers as outlined in the Recall Notice issued by Jamp Pharma Corporation.

Healthcare professionals should also contact the patients who used the affected lots and had negative test results, and consider repeating the oral glucose challenge or tolerance test, or using an alternate diagnostic test.

Action taken by Health Canada

Health Canada is communicating this important safety information update to healthcare professionals and Canadians via the Recalls and Safety Alerts Database on the Healthy Canadians Web Site. This communication update will be further distributed through the MedEffect™ e-Notice email notification system.

Report health or safety concerns

Managing marketed health product-related side effects depends on healthcare professionals and consumers reporting them. Any case of false negative glucose challenge or tolerance test or other serious or unexpected side effects in patients receiving Jamp-Glucose 50 and Jamp-Glucose 75 should be reported to Jamp Pharma Corporation or Health Canada.

Jamp Pharma Corporation
1310 Nobel, Boucherville, Qc, J4B 5H3
1-866-399-9091
serviceclient@jamppharma.com

To correct your mailing address or fax number, contact Jamp Pharma Corporation.

You can report any suspected adverse reactions associated with the use of health products to Health Canada by:

  • Calling toll-free at 1-866-234-2345; or
  • Visiting MedEffect Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

For other health product inquiries related to this communication, contact Health Canada at:

Marketed Health Products Directorate
E-mail: mhpd_dpsc@hc-sc.gc.ca   
Telephone: 613-954-6522  
Fax: 613-952-7738