CanadaSterimax Inc. Remifentanil hydrochloride for injection 1 mg/vial (powder for solution; DIN 02366460) in lots 243101O, 243110D and 253101D is being recalled to wholesalers. The assay and impurity are out of specification; verify if your product is affected, consult your healthcare provider before discontinuing use, contact Sterimax Inc. with questions, and report any health product side effects or other safety complaints to Health Canada.
What's being recalled
Depth of recall: Wholesalers
Companies: Sterimax Inc., 2770 Portland Drive, Oakville Ontario L6H 6R4 Canada.
How to identify it
Brand: Sterimax Inc.; Product Name: Remifentanil hydrochloride for injection; Market Authorization: DIN 02366460; Dosage Form: Powder for solution; Strength: Remifentanil hydrochloride 1 mg/vial; Lot Number: 243101O, 243110D, 253101D
The hazard
The assay and impurity is out of specification in the affected lots.
What to do
Verify if your product is affected.
Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any health concerns.
Contact the recalling firm if you have any questions about the recall.
Report any health product related side effects to Health Canada.
Report any other health product safety complaints to Health Canada.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)