Health Product InfoWatch – August 2017
Health Products and Food Branch
Marketed Health Products Directorate
Health Product InfoWatch Editorial Team
Scope, reporting and contact information, helpful links
Contents
- Announcement: Recalls and safety alerts mobile application
- Monthly recap
- New information
- Product monograph update: Invokana (canagliflozin) and Invokamet (canagliflozin and metformin)
- Product monograph update: Revlimid (lenalidomide)
- Product monograph update: Temodal (temozolomide)
- Product monograph update: Videx EC (didanosine)
- Product monograph update: Zelboraf (vemurafenib)
- Vaccine safety quarterly summary: Report for October 1, 2016 to December 31, 2016
ISSN 2368-8025
Pub. no 160256
Health products mentioned in this issue
Pharmaceuticals and Biologics
- Amino-acid solutions for parenteral nutrition
- Erwinase for injection
- Gentamicin Injection USP
- Invokamet (canagliflozin and metformin)
- Invokana (canagliflozin)
- PMS-Propofol
- RestoraLAX 30 + 7 Bonus Pack
- RestoraLAX 45 + 10 Value Pack
- Revlimid (lenalidomide)
- Temodal (temozolomide)
- Videx EC (didanosine)
- Zelboraf (vemurafenib)
Medical Devices
Other
Announcement
Recalls and safety alerts mobile application
The free "Recalls and safety alerts" application for Apple, Android and BlackBerry delivers up-to-date and reliable health and safety information right to your mobile phone.
An up-to-date list of health product recalls and advisories can be found by clicking the health products button. 
This app also offers a search option which will provide the latest information on a specific health product.
The "Recalls and safety alerts" application can be downloaded from your smartphone using:
For more information please visit the recalls and safety alerts mobile application Web page.
Monthly recap of health product safety information
The following is a list of health product advisories, type I recalls as well as summaries of completed safety reviews published in July 2017 by Health Canada.
Amino-acid solutions for parenteral nutrition
This safety review evaluated the risk of death in premature infants when fed with amino-acid solutions for parenteral nutrition that were not protected from light when administered. Health Canada's review concluded that there was not enough information available to confirm a link. Health Canada will continue to monitor this issue.
Summary Safety Review- Amino-acid solutions for parenteral nutrition
Erwinase for injection
The Erwinase product from batch CAMR 182 H117 that is now being distributed in Canada has Canadian labelling and not UK labelling as mentioned in previous risk communications. If particulate matter is observed elsewhere other than on the underside of the stopper (e.g., on or in the product) before or after reconstitution, the product should not be administered and should be retained for collection. A standard 5-micron filter needle should be used to withdraw the reconstituted product from the vial prior to administration as a precautionary measure.
Health Professional Risk Communication- Erwinase for injection
Foreign health products
These foreign health products have been found by regulators in other countries to contain undeclared drug ingredients. These products are not authorized for sale in Canada and have not been found in the Canadian marketplace but it is possible they may have been brought into the country by travellers or purchased over the Internet.
Gentamicin Injection USP
Twelve lots of Gentamicin Injection USP (10 mg/mL and 40 mg/mL) manufactured at Sandoz Canada Inc. may contain traces of histamine. Histamine administered intravenously or intramuscularly could potentially lead to signs and symptoms of anaphylaxis, particularly in pediatric patients and patients with severe renal impairment. Although the likelihood of this adverse event is rare, all patients administered Gentamicin Injection USP from the affected lots should be closely monitored for adverse reactions associated with elevated levels of histamine.
Health Professional Risk Communication- Gentamicin Injection USP
Intraocular lenses
This safety review evaluated the risk of the development of glistening associated with the use of intraocular lenses. Health Canada's review concluded that the available evidence is not strong enough to determine how or why glistening develops, and if it changes the quality of a person's vision. Health Canada will continue to monitor this issue.
Summary Safety Review- Intraocular lenses
NovoPen Echo and NovoPen 5 insulin cartridge holders
Insulin cartridge holders used in certain lots of NovoPen Echo and NovoPen 5 insulin pens were recalled by Novo Nordisk A/S. The company detected that the cartridge holders may crack or break if exposed to certain chemicals, such as some cleaning agents, which could result in a smaller dose of insulin than expected.
Advisory- NovoPen Echo and NovoPen 5 insulin cartridge holders
PMS-Propofol
PMS-Propofol (lot number A060200) was recalled by Pharmascience Inc. as the affected lot may contain glass particles.
RestoraLAX 30 + 7 Bonus Pack and RestoraLAX 45 + 10 Value Pack
Health Canada advised Canadians that Bayer Inc. recalled specific lots of RestoraLAX 30 + 7 Bonus Pack sold at various retailers across Canada and specific lots of RestoraLAX 45 + 10 Value Pack sold at Costco Canada. The recalled products may contain deposits such as clumps or lumps which may pose a choking hazard.
- Advisory- RestoraLAX 30 + 7 Bonus Pack
- Advisory- RestoraLAX 45 + 10 Value Pack
- Drug Recall- RestoraLAX 30 +7 Bonus Pack
- Drug Recall- RestoraLAX 45 + 10 Value Pack
Unauthorized health products
Health Canada advised Canadians about various unauthorized health products being sold at retail locations across Canada or online.
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