This page has been archived on the Web

Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.

Health professional risk communication

Certain Sandoz Products for Injection - Possible Volume Under-Fill of Some Vials - For Health Professionals

Starting date:
August 2, 2013
Posting date:
August 2, 2013
Type of communication:
Dear Healthcare Professional Letter
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Important Safety Information
Audience:
Healthcare Professionals
Identification number:
RA-34873

This is duplicated text of a letter from Sandoz Canada Inc. Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

Health Canada Endorsed Important Safety Information on certain Sandoz products for injection

August 2, 2013

Subject:     Possible volume under-fill of some vials for certain Sandoz injectable products

Dear Healthcare Professional,

Sandoz Canada Inc., in consultation with Health Canada, would like to inform you of a possible under-fill of certain Sandoz products for injection distributed in vials.

The quality and concentrations of the products are not affected. However, the total available drug content in the under-filled vials would be lower than labelled. The entire lot is not impacted, however isolated cases may exist.

  • A full list of Sandoz injectable product lots that could be potentially affected by this under-fill issue may be found in Table 1.
  • All the potentially affected products have a flip-top closure. Since a needle and syringe are required to withdraw the volume needed to administer as prescribed, under-filled vials would likely be noticed and therefore the likelihood of administration of a low dose with an under-filled vial is considered to be extremely low.
  • Ensure that appropriate dose and volume are administered to patients.

Please note that Sandoz has taken appropriate corrective measures to ensure that all future lots are manufactured in accordance with the product specifications as approved by Health Canada.

Should you have any questions or product with suspected low volume, please contact either your Sandoz Sales Representative or our Customer Service by telephone at 1-800-361-3062 or by e-mail to: info.clients@sandoz.com.

Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any case of serious or unexpected adverse reaction related to under-dosing in patients receiving a Sandoz product should be reported to Sandoz or Health Canada.

Sandoz Canada Inc.
145 Jules Léger
Boucherville, Quebec, Canada
J4B 7K8
Tel: 1-800-343-8839 ext. 4636
Fax: 1-888-243-6221

To correct your mailing address or fax number, contact Sandoz Canada Inc.

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, please contact Health Canada at:
Health Products and Food Branch Inspectorate
E-mail: DCVIU_UVECM@hc-sc.gc.ca
Telephone: 1-800-267-9675
Fax: 613-946-5636

We apologize for any inconvenience which this situation may cause.

Sincerely yours,

original signed by

Daniel Larrimore
Vice-President, Quality

Len Arsenault
Vice-President, Scientific Affairs

ANNEX

Table 1: List of products
Product Lot number Expiry DIN
DEXAMETHASONE 10MG/ML 1ML 10LIVI CA BF8946 2013-12-31 00874582
DIMENHYDRINATE IM 50MG/ML 5ML 10LIVI CA CU6582 2015-09-30 00392537
DIPHENHYDRAMINE HCL 50MG/1ML 10LIVI CA BE7297 2013-11-30 00596612
FENTANYL CIT 50MCG/ML 20ML 5LIVI CA BJ7385 2014-01-31 02240434
FENTANYL CIT 50MCG/ML 20ML 5LIVI CA BW5569 2014-08-31 02240434
FENTANYL CIT 50MCG/ML 20ML 5LIVI CA CG8279 2015-02-28 02240434
FENTANYL CIT 50MCG/ML 20ML 5LIVI CA CP5527 2015-06-30 02240434
FENTANYL CIT 50MCG/ML 20ML 5LIVI CA CX1982 2015-10-31 02240434
FENTANYL CIT 50MCG/ML 20ML 5LIVI CA CX2831 2015-10-31 02240434
FENTANYL CIT 50MCG/ML 20ML 5LIVI CA DC1521 2016-01-31 02240434
FENTANYL CIT 50MCG/ML 20ML 5LIVI CA DF0488 2016-03-31 02240434
FENTANYL CIT 50MCG/ML 20ML 5LIVI CA DG7913 2016-04-30 02240434
FENTANYL CITRATE 50MCG/ML 5ML 5LIVI CA CE6639 2015-01-31 02240434
FENTANYL CITRATE 50MCG/ML 5ML 5LIVI CA CE8594 2015-01-31 02240434
FENTANYL CITRATE 50MCG/ML 5ML 5LIVI CA CN9591 2015-06-30 02240434
FENTANYL CITRATE 50MCG/ML 5ML 5LIVI CA CV2666 2015-09-30 02240434
FENTANYL CITRATE 50MCG/ML 5ML 5LIVI CA CZ4561 2015-11-30 02240434
FENTANYL CITRATE 50MCG/ML 5ML 5LIVI CA DC6482 2016-01-31 02240434
FENTANYL CITRATE 50MCG/ML 5ML 5LIVI CA DF7605 2016-03-31 02240434
FUROSEMIDE 10MG/ML 4ML 10LIVI CA CB7433 2013-11-30 00527033
GENTAMICIN 40MG/ML 20ML 1LIVI CA BS5665 2014-05-31 02242652
GENTAMICIN 40MG/ML 20ML 1LIVI CA CR8331 2015-07-31 02242652
GENTAMICIN 40MG/ML 20ML 1LIVI CA CS4945 2015-07-31 02242652
GENTAMICIN 40MG/ML 2ML 10LIVI CA BF4760 2013-11-30 02242652
GENTAMICIN 40MG/ML 2ML 10LIVI CA CB5950 2014-11-30 02242652
GENTAMICIN 40MG/ML 2ML 10LIVI CA CS6549 2015-07-31 02242652
GLYCOPYRROLATE 0.2MG/ML 20ML 1LIVI CA CM3179 2014-05-31 02039508
GLYCOPYRROLATE 0.2MG/ML 20ML 1LIVI CA CR7529 2014-07-31 02039508
GLYCOPYRROLATE 0.2MG/ML 20ML 1LIVI CA CV1944 2014-09-30 02039508
GLYCOPYRROLATE 0.2MG/ML 20ML 1LIVI CA CW2810 2014-09-30 02039508
GLYCOPYRROLATE 0.2MG/ML 2ML 10LIVI CA CL0519 2013-10-31 02039508
HYDROMORPHONE HCL 2MG/ML 1ML 10LIVI CA BD8443 2013-10-31 02145901
HYDROMORPHONE HCL 2MG/ML 1ML 10LIVI CA BE3948 2013-10-31 02145901
HYDROMORPHONE HCL 2MG/ML 1ML 10LIVI CA BG1189 2013-12-31 02145901
HYDROMORPHONE HCL 2MG/ML 1ML 10LIVI CA BG1191 2013-12-31 02145901
HYDROMORPHONE HCL 2MG/ML 1ML 10LIVI CA BK2807 2014-01-31 02145901
HYDROMORPHONE HCL 2MG/ML 1ML 10LIVI CA BK2798 2014-02-28 02145901
HYDROMORPHONE HP 10 5ML 5LIVI CA CC1833 2014-12-31 02145928
HYDROMORPHONE HP 10 5ML 5LIVI CA CJ7015 2015-03-31 02145928
HYDROMORPHONE HP 10 5ML 5LIVI CA DA3330 2015-12-31 02145928
HYOSCINE BUTYLBR 20MG/ML 1ML 10LIVI CA CZ4566 2014-11-30 02229868
KETOROLAC TROME 30MG/ML 1ML 10LIVI CA CJ0963 2013-09-30 02239944
KETOROLAC TROME 30MG/ML 1ML 10LIVI CA DA1068 2014-06-30 02239944
LABETALOL HCL 5MG/ML 20ML 1LIVI CA CS5559 2014-01-31 02231689
LABETALOL HCL 5MG/ML 20ML 1LIVI CA CS5560 2014-01-31 02231689
LABETALOL HCL 5MG/ML 20ML 1LIVI CA DA1735 2014-06-30 02231689
LABETALOL HCL 5MG/ML 20ML 1LIVI CA DG1688 2014-09-30 02231689
LORAZEPAM 4MG/ML 1ML 10LIVI CA CA9283 2013-11-30 02243278
LORAZEPAM 4MG/ML 1ML 10LIVI CA CR5628 2014-07-31 02243278
LORAZEPAM 4MG/ML 1ML 10LIVI CA CY3838 2014-10-31 02243278
METOCLOPRAMIDE HCL 5MG/ML 2ML 10LIVI CA CB5014 2014-11-30 02185431
METOCLOPRAMIDE HCL 5MG/ML 2ML 10LIVI CA CF4312 2015-01-31 02185431
METOCLOPRAMIDE HCL 5MG/ML 2ML 10LIVI CA CF5242 2015-01-31 02185431
METOCLOPRAMIDE HCL 5MG/ML 2ML 10LIVI CA CX1250 2015-10-31 02185431
METOCLOPRAMIDE HCL 5MG/ML 2ML 10LIVI CA DD1278 2016-02-29 02185431
METOPROLOL TAR 1MG/ML 5ML 5LIVI CA CJ3587 2015-03-31 02267853
METOPROLOL TAR 1MG/ML 5ML 5LIVI CA CJ8441 2015-03-31 02267853
MIDAZOLAM 1MG/ML 5ML 10LIVI CA BY8331 2013-10-31 02240285
MIDAZOLAM 1MG/ML 5ML 10LIVI CA CF6160 2014-02-28 02240285
MIDAZOLAM 1MG/ML 5ML 10LIVI CA DE0772 2015-02-28 02240285
MORPHINE HP 50 1ML 10LIVI CA CK9592 2013-10-31 00617288
MORPHINE LP EPI 0.5MG/ML 10ML 5LIVI CA DE3523 2015-02-28 02021056
ONDANSETRON 2MG/ML 4ML 5LIVI CA BT5186 2014-06-30 02279428
PHENYLEPHRINE HCL 10MG/ML 1ML 10LIVI CA BE8753 2013-11-30 01953583
PHENYLEPHRINE HCL 10MG/ML 1ML 10LIVI CA BT2045 2014-06-30 01953583
PHENYTOIN NA 50MG/ML 2ML 10LIVI CA CJ8539 2015-04-30 00780626
PROTAMINE SO4 10MG/ML 5ML 10LIVI CA BE6808 2013-11-30 02231674
PROTAMINE SO4 10MG/ML 5ML 10LIVI CA DA4050 2015-12-31 02231674
SUFENTANIL CIT 50MCG/ML 5ML 5LIVI CA CJ3588 2014-03-31 02244147
SUFENTANIL CIT 50MCG/ML 5ML 5LIVI CA DD5106 2015-02-28 02244147
TOBRAMYCIN 40MG/ML 2ML 10LIVI CA BK0123 2014-02-28 02241210
TOBRAMYCIN PF 40MG/ML 2ML 10LIVI CA BB7711 2013-09-30 02241210
TOBRAMYCIN PF 40MG/ML 2ML 10LIVI CA BC1835 2013-09-30 02241210
TOBRAMYCIN PF 40MG/ML 2ML 10LIVI CA CJ5295 2015-03-31 02241210
VERAPAMIL HCL 2.5MG/ML 2ML 10LIVI CA CM0627 2014-05-31 02166739
VERAPAMIL HCL 2.5MG/ML 2ML 10LIVI CA CN8132 2014-05-31 02166739
VITAMIN B12 1000MCG/ML 10ML 1LIVI CA BF0478 2013-11-30 00521515