Informal Request for ATI Records Previously Released

Organization: Health Canada

Year: 2022

Month: September

Request Number: A-2022-000243

Request Summary: Health Canada issued a public advisory (Identification #RA-64122) on April 28, 2022 advising that Apotex Inc. is recalling five lots of Apo-Acyclovir tablets, in 200 mg and 800 mg strengths, due to the presence of N-nitrosodimethylamine (NDMA) above the acceptable level. Copies of any documentation or other information identifying the quantity of pills affected by the recall as well as the levels and/or concentrations of NDMA detected through testing of the recalled Apo-Acyclovir tablets. Any information in Health Canada’s possession concerning distribution of Apo-Acyclovir lots contaminated with NDMA by Apotex outside of Canada.

Disposition: Disclosed in part

Number of pages: 10

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