Health Canada
www.hc-sc.gc.ca
Common menu bar links
Institutional links
Certain Sandoz Products for Injection - Possible Fading of the Expiry Date and Lot Number on Labels of Vials of 10 mL or Less - For Health Professionals
Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.
(PDF Version - 49 K)Contact: Health Products and Food Branch Inspectorate
The Health Products and Food Branch (HPFB) posts on the Health Canada Web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.
This is duplicated text of a letter from Sandoz Canada Inc.
Contact the company for a copy of any references, attachments or enclosures.
Health Canada Endorsed Important Safety Information on certain Sandoz products for injection
August 4, 2011
Subject: Possible fading of the expiry date and lot number on labels of vials of 10 mL or less for certain Sandoz products for injection
Dear Health Care Professional,
Sandoz Canada Inc., in consultation with Health Canada, would like to inform you of possible fading of the expiry date and lot number on the label of certain Sandoz products for injection distributed in vials of 10 mL or less. Please note that vials of more than 10 mL and ampoules of all formats are not affected by this situation.
As the quality of the product is not affected, it was decided not to recall all these products at this time in order to ensure availability of these products to those patients who need them. Please note that Sandoz has already implemented corrective actions to remedy this situation.
- Healthcare Professionals should always verify the expiry date of the product before administration to a patient.
- If the product is expired, or the lot number or expiry date is not visible, the product should not be used.
- Healthcare Professionals should verify the legibility of the labels of the vials of the products listed in Tables 1 and 2 (attached to this letter) in inventory in their institution, with particular attention to those indicated and stored for emergency use.
- This verification should be done now and periodically since fading of currently legible lot numbers and expiry dates could take place over time.
Current data indicates that Lorazepam Injection USP would be the product most affected by this situation. However, Sandoz has received complaints of this nature for other products, which are listed in Table 1 attached to this letter. Sandoz asks that Healthcare Professionals verify the vials of products listed in Table 1 in their inventory. No adverse events have been reported in relation to fading of the lot number and expiry date on the vial labels.
Additionally, as other products distributed in vials of 10 mL or less could also be affected, Sandoz recommends that Healthcare Professionals also pay attention to such products. Certain of these products could be used in emergency situations (such as the ones listed in Table 2 in the annex - please note that this list is not exhaustive), and it is recommended that verification of the products for emergency use in your institution be given priority. A full list of Sandoz injectable products that could potentially be affected by this labelling issue may be found at:
http://www.sandoz.ca/site/en/products/validator/index2.shtml
In the event that a vial is found with illegible lot number or expiry date, please contact our drug information department at 1-800-343-8839 (4636) or at medinfo@sandoz.com.
Considering that the currently legible lot number and expiry date could fade over time, this verification should be done periodically. Sandoz also recommends that the vials be stored in their original boxes whenever possible since the lot number and expiry date are fully legible on the boxes and not subject to fading.
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 in patients receiving a Sandoz product in a vial of 10 mL or less for which the lot number or expiry date is not legible should be reported to Sandoz or Health Canada.
Sandoz Canada Inc.
145 Jules Léger
Boucherville, Quebec, Canada
J4B 7K8
Telephone: 1-800-343-8839 ext. 4636
Fax: 1-888-243-6221
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Reporting Form and:
- - Fax toll-free to 1-866-678-6789, or
- - Mail to: Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa, Ontario K1A 0K9
The Reporting Forms, postage paid labels, and Guidelines can be found on the MedEffect™ Canada Web site in the Adverse Reaction Reporting section. The Reporting Form is also in the Canadian Compendium of Pharmaceuticals and Specialties.
For other health product inquiries related to this communication, please contact Health Canada at:
Health Products and Food Branch Inspectorate
E-mail: DCVIU_UVCEM@hc-sc.gc.ca
Telephone: 613-952-9906
Fax: 613-946-5636
To change your mailing address or fax number, contact the Market Authorization Holder (Industry).
We apologize for any inconvenience which this situation may cause.
Sincerely yours,
original signed by
Leonard J. Arsenault
Vice-President, Scientific Affairs
Simona Surdila
Vice-President, Quality
ANNEX
| Product | DIN |
|---|---|
| Dexamethasone Sodium Phosphate Injection USP 10 mg/mL | 00874582 |
| Glycopyrrolate Injection USP 0.2 mg/mL | 02039508 |
| Hyoscine Butylbromide Injection 20 mg/mL | 02229868 |
| Ketamine Hydrochloride Injection USP 10 mg/mL | 02246795 |
| Lorazepam Injection USP 4 mg/mL | 02243278 |
| Metoclopramide Hydrochloride Injection 5 mg/mL | 02185431 |
| Midazolam Injection 1 mg/mL | 02240285 |
| Midazolam Injection 5 mg/mL | 02240286 |
| Morphine HP 50, 50 mg/mL | 00617288 |
| Morphine LP Epidural 0.5 mg/mL | 02021056 |
| Norepinephrine Bitartrate Injection USP 1 mg/mL | 00893285 |
| Ondansetron Injection USP 2 mg/mL | 02279428 |
| Pancuronium Bromide Injection 1 mg/mL | 02169622 |
| Phenylephrine Hydrochloride Injection USP 10 mg/mL | 01953583 |
| Verapamil Hydrochloride Injection USP 2.5 mg/mL | 02166739 |
| Product | DIN |
|---|---|
| Alcohol (Dehydrated) Injection USP 100% v/v | 00394394 |
| Amiodarone Hydrochloride for Injection | 02242325 |
| Dexamethasone Sodium Phosphate Injection USP | 00874582 00664227 |
| Diltiazem Hydrochloride Injection | 02244728 |
| Diphenhydramine Hydrochloride Injection USP | 00596612 |
| Fentanyl Citrate Injection USP | 02240434 |
| Flumazenil Injection | 02249561 |
| Furosemide Injection USP | 00527033 |
| Glycopyrrolate Injection USP | 02039508 |
| Heparin Sodium Injection USP | 02303086 02303094 02303108 |
| Ketamine Hydrochloride Injection USP | 02246795 02246796 |
| Lorazepam Injection USP | 02243278 |
| Magnesium Sulfate Injection USP | 00392618 00602264 |
| Metoprolol Tartrate Injection USP | 02267853 |
| Midazolam Injection | 02240285 02240286 |
| Nitroglycerin Injection USP | 00860778 |
| Norepinephrine Bitartrate Injection USP | 00893285 |
| Phenylephrine Hydrochloride Injection USP | 01953583 |
| Phenytoin Sodium Injection USP | 00780626 |
| Propranolol Hydrochloride Injection USP | 02225883 |
| Vasopressin Injection USP | 02247938 |
| Verapamil Hydrochloride Injection USP | 02166739 |
