Importation restrictions of drugs linked to Hospira S.P.A. due to data integrity concerns
- Starting date:
- June 12, 2015
- Posting date:
- June 12, 2015
- Type of communication:
- Information Update
- Source of recall:
- Health Canada
- Important Safety Information, New safety information
- General Public
- Identification number:
Health Canada is restricting the importation of drugs from Hospira S.P.A. in Liscate, Italy, due to data integrity concerns. This measure is to help mitigate any potential risk in light of recent findings from a trusted regulatory partner that raised concerns about the reliability of the laboratory data generated at this site.
The licences of Canadian companies that import drugs from this facility are being amended with terms and conditions that require independent third-party testing against the approved Canadian specifications prior to release of any medically necessary products to the Canadian market. Independent, third-party testing will provide confidence that the affected medically necessary products meet Canadian quality standards before being released for use by Canadians.
Products from this site that are not on the medically necessary list will not be imported or released on to the Canadian market until Health Canada is satisfied that the data integrity issues at the facility have been addressed. Canadian importers have been requested to voluntarily quarantine such non-medically necessary products until the terms and conditions come into effect.
Health Canada has compiled a list of marketed products affected by the importation restrictions. The list will be updated as new information becomes available. The Department will continue to keep Canadians informed through updates on the Inspection Tracker.
Canadians should not make any changes to their medication without first consulting with a healthcare professional.
Health Canada will continue to work with international partners and Canadian importers to gather and assess information regarding the situation and take action as necessary to help protect Canadians.
Health Canada will also engage the provinces and territories to share information about the situation.