The following sites were affected: Apotex Pharmachem India Pvt Ltd (APIPL), Apotex Research Private Limited (ARPL), and IPCA Laboratories. The action applies to finished products from ARPL, as well as active pharmaceutical ingredients (APIs) and products made with APIs from APIPL and IPCA. Health Canada has compiled an initial list of products affected by the import ban. The list will be updated as new information becomes available. Certain medically necessary products may be excluded from the action on the condition they are tested by an independent third party before being released for use or sale. Independent testing against specifications will provide confidence that these products meet Canadian quality standards, and will allow consumers to have continued access to medically necessary and safe products.

When data integrity issues were first identified at each of these sites by the U.S. Food and Drug Administration (FDA), Health Canada took action to protect the health and safety of Canadians. There is currently a voluntary quarantine on products from ARPL and IPCA. Products from APIPL have been undergoing additional testing, as required by Health Canada before being allowed on the Canadian market.