Jamp-Glucose Supplement Recall [Canada]


Canada FlagCanada/Ottawa: Jamp Pharma branded Jamp-Glucose Supplement Recall [Canada]Jamp Pharma Corporation, a Boucherville, Quebec establishment, has recalled three (3) batch/lots of Jamp-Glucose 50 and three (3) lots of Jamp-Glucose 75 D-glucose Supplements due to insufficient levels of D-glucose and consequential risk of false negative Oral Glucose Challenge or Tolerance Test results and failure to correctly screen and diagnosis Diabetes, all serious health hazards.

HCSC: http://ht.ly/2FJ630kyXWj

Direct link: http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2018/67008a-eng.php

Additional information:
Health Canada/Santé Canada (“HCSC”) reports the following D-Glucose Supplements are subject to this recall:

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, as follows:

  • Jamp-Glucose 50, sold with an NPN of 80046733 and three batch/lots:
    • Batch/lot 1708012 with an expiry of 2019-02 and distributed from 2017-11-30 to 2018-04-20
    • Batch/lot 1707002 with an expiry of 2018-12 and distributed from 2017-07-24 to 2018-02-26
    • Batch/lot 1703001 with an expiry of 2018-08 and distributed from 2017-03-02 to 2017-07-24
  • Jamp-Glucose 75, sold with an NPN of 80046741 and three batch/lots:
    • Batch/lot 1711034 with an expiry of 2019-05 and distributed from 2018-02-13 to 2018-04-20
    • Batch/lot 1707001 with an expiry of 2018-12 and distributed from 2017-08-23 to 2018-02-09
    • Batch/lot 1703002 with an expiry of 2018-08 and distributed from 2017-04-07 to 2017-08-24

Background:
Jamp-Glucose 50 and Jamp-Glucose 75 are used as part of oral glucose tests for screening and diagnosis of Diabetes.

A common approach to screening for Gestational Diabetes in pregnant women is the use of a 50 Risk of False Negative Oral Glucose Challenge or Tolerance Test Results glucose challenge test in the late second trimester, followed by a 75 gram oral glucose tolerance test if the 50 gram 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.

According to Health Canada, Jamp Pharma Corporation has recalled a total of six (6) batch/lots of Jamp-Glucose 50 and Jamp-Glucose 75 because they contain less glucose than is shown on their labels. This 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.

Physicians and other health professionals are advised to follow this action plan:

  1. Immediately stop using the affected lots and return them to the wholesalers as outlined in the Recall Notice issued by Jamp Pharma Corporation here: http://www.jamppharma.ca/media/files/group/19._HPRC_Jamp_Glucose_V2.6_EN__HC_without_SQ_signature.pdf.
  2. Contact the patients who had negative Oral Glucose Challenge or Oral Glucose Tolerance test results involving the affected batch/lots, and consider repeat testing, or use an alternate diagnostic test for Diabetes as appropriate.

If you have any questions about this recall notification, please contact Jamp Pharma Corporation at 1310 Nobel, Boucherville, Quebec, J4B 5H3 or by phone at 1-866-399-9091 or by e-mail at serviceclient@jamppharma.com.

==> Patients should contact their healthcare professional if they have any questions or concerns about this recall.

Please note: the Canada Consumer Product Safety Act prohibits recalled products from being redistributed, sold or even given away in Canada.

==> To see other recalls and notifications for products manufactured, marketed and/or sold by Jamp Pharma Corporation, please search for “Jamp Pharma” using the Search Box at the top of this page.

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More information about this recall:
HCSC ID number: RA-67008
Recalls Direct RIN: 10313-2018
Want to read more about this recall?
==> Please click on the links above to visit the originating site.
Want to read more about other recalls?
==> Please click on the links below.

General information:
More recalls? Back to the main Recalls Direct page:
==> http://www.RecallsDirect.com/
About the Recalls Direct service:
==> http://wp.me/P2bVty-2
Visit the Living Safely site:
==> http://www.LivingSafely.org/
Report an unsafe product you purchased in Canada [external: new window opens]:
==> http://www.hc-sc.gc.ca/cps-spc/advisories-avis/incident/index-eng.php
Search for a recalled product on the Health Canada Web site [external: new window opens]:
==> http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/index-eng.php

We welcome your feedback:
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E. & O. E.

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