Cisatracurium Omega Multi-Dose (Cisatracurium Besylate Injection): Temporary change of ferrule (metal seal) colour to maintain continued supply in Canada

Starting date:
May 25, 2020
Posting date:
May 25, 2020
Type of communication:
Dear Healthcare Professional Letter
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Supply, Product Safety, Important Safety Information
Audience:
Healthcare Professionals, Hospitals
Identification number:
RA-73179

Last updated:

Audience

Healthcare professionals including pharmacists, anesthesiologists, critical care physicians, emergency physicians and those involved with administering anesthesia or intubating patients.

Key messages

  • There is an increased demand and shortage in Canada for Cisatracurium Besylate Injection as a result of the COVID-19 pandemic.
  • Cisatracurium Besylate Injection is a non-depolarizing neuromuscular blocking (NMB) agent. Given the medical necessity of this product in Canada, and to maintain a continued supply in Canada, Health Canada has authorized a temporary colour change of the ferrule (metal seal) from teal to red for Cisatracurium Omega Multi-Dose (Cisatracurium Besylate Injection) 20 mg/10 mL (2 mg/mL) vials. This is a temporary change that will remain in place until additional inventory is received by Omega.
  • Healthcare professionals are advised that:
    • Cisatracurium Omega Multi-Dose vials will temporarily be supplied with a red ferrule (metal seal) instead of a teal ferrule.
    • The temporary red ferrule (metal seal) will include the standard warning “Paralyzing Agent” imprint.
    • There is a potential risk of errors resulting from inadvertent selection and administration of NMBs, resulting in serious harm to patients.
  • Proper selection of the intended product must be confirmed to avoid confusion with other injectable products, including other NMBs commonly supplied with a distinctive red cap and metal seal.

    

Issue

There is an increased demand and shortage in Canada for Cisatracurium Besylate Injection, as a result of the COVID-19 pandemic. Given the medical necessity of this product in Canada, and to maintain a continued supply, Health Canada has authorized a temporary colour change of the ferrule (metal seal) from teal to red, for Cisatracurium Omega Multi-Dose (Cisatracurium Besylate Injection) 20 mg/10mL (2 mg/mL) 10 mL vials. This temporary change is due to delays in receiving the caps with a teal ferrule and will remain in place until additional inventory is received by Omega.

Products affected

Cisatracurium Omega Multi-Dose
Cisatracurium, 20 mg/10 mL (2 mg/mL); 10mL vial
DIN 02408813

Background information

Cisatracurium Besylate Injection is a non-depolarizing skeletal neuromuscular blocking agent (NMB) with an intermediate onset and duration of action indicated as an adjunct to general anesthesia, to facilitate non-emergency endotracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.

Cisatracurium Omega Multi-Dose will temporarily be supplied with a red ferrule (metal seal on vial) with white lettering: “Paralyzing Agent” on the container closure in place of a teal ferrule.

Who is affected

Information for healthcare professionals

This drug should be administered by appropriately trained healthcare professionals, familiar with its actions, characteristics, and hazards.

In Canada, NMBs are commonly supplied with a distinctive red ferrule (metal seal on vial) with white lettering: “Warning: Paralyzing Agent” or “Paralyzing Agent”. Canadian healthcare professionals who administer NMBs are accustomed to this labelling and packaging practice, which has been adopted by industry as a strategy to readily identify NMBs so that they are not confused with other products.

Contrary to other NMBs commonly supplied with a red cap and ferrule (metal seal), Cisatracurium Omega Multi-Dose is usually supplied with a teal ferrule. Although the introduction of this temporary colour change to red for this product will be consistent with other NMBs supplied in Canada, this change may increase the risk of selection errors with other NMBs given healthcare professional familiarity with the product supplied in a teal colour.

Healthcare professionals are advised that:

  • Cisatracurium Omega Multi-Dose vials will temporarily be supplied with a red ferrule (metal seal) instead of a teal ferrule. 
  • The temporary red ferrule (metal seal) will continue to include the warning “Paralyzing Agent” imprint.
  • There is a potential risk of errors resulting from inadvertent selection and administration of NMBs, resulting in serious harm to patients.

Health Canada is aware of domestic and international reports of NMB mix-ups causing serious harm including death; some of these errors are related to changes in the labelling and packaging of these products.

Proper selection of the intended product must be confirmed to avoid confusion with other injectable products, including other NMBs commonly supplied with a distinctive red cap and ferrule (metal seal).

Action taken by Health Canada

Health Canada has worked with Omega Laboratories Ltd to prepare this alert for Cisatracurium Omega Multi-Dose. Health Canada is communicating this important safety information update to healthcare professionals and Canadians via the Recalls and Safety Alerts Database on the Healthy Canadians Web Site. This communication update will be further distributed through the MedEffect™ e-Notice email notification system as well as social media channels including LinkedIn and Twitter.

Report health or safety concerns

Managing marketed health product-related side effects depends on healthcare professionals and consumers reporting them. Any case of serious or unexpected side effects in patients receiving Cisatracurium Omega Multi-Dose (Cisatracurium Besylate Injection) 20 mg/10 mL (2 mg/mL) should be reported to Omega Laboratories Limited or Health Canada.

Omega Laboratories Limited
11,177 Hamon, Montréal, Québec H3M 3E4
Telephone : (514) 335.0310 / 1.800.363.0584
Fax : (514) 339.1407
E-mail: pharmacovigilance@omegalabs.ca

To correct your mailing address or fax number, contact Omega Laboratories Limited.

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, contact Health Canada at:

Regulatory Operations and Regions Branch
E-mail: hc.hpce-cpsal.sc@canada.ca
Telephone: 1-800-267-9675

Original signed by

Stéphane Bélanger
Head, Quality Operations
Omega Laboratories Limited

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