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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
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 |