Health Canada, the national regulatory agency of 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 tregulatory partner that raised concerns about the reliability of the laboratory data generated at this site,” said Health Canada in a June 12, 2015 announcement.

Health Canada reports that the licenses 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.

Source: Hospira