Public advisory - One lot of ratio-ECTOSONE (TEVA-ECTOSONE) 0.05% mild lotion recalled due to an impurity that may pose health risks

OTTAWA, ON, June 28, 2024 /CNW/ -

Summary

ratio-ECTOSONE (TEVA-ECTOSONE) 0.05% mild lotion, 60 mL (CNW Group/Health Canada (HC))

• Products: ratio-ECTOSONE (TEVA-ECTOSONE) 0.05% mild lotion, 60 mL (DIN 00653209, lot 688519)
• Issue: Health products – Product quality
• What to do: Do not use this product. Consult a health care professional if you have used this product and have health concerns. Return products to your local pharmacy for proper disposal.

Affected products

Product	DIN	Lot	Expiry
ratio-ECTOSONE (TEVA-ECTOSONE) 0.05% mild lotion, 60 mL	00653209	688519	06/2024

Issue

Teva Canada Ltd. is recalling one lot of ratio-ECTOSONE (TEVA-ECTOSONE) 0.05% mild lotion in 60 mL bottles. This action follows testing that detected an impurity—betamethasone enol aldehyde—above the accepted limit in the affected lot. This impurity can form due to a chemical change in the drug during storage and may pose health risks, including the possibility of adverse reactions on the skin or elsewhere in the body from being absorbed into the bloodstream. The risk may be greater in children who may absorb proportionally larger amounts of the impurity and be more susceptible to adverse reactions.

The product is a prescription corticosteroid lotion used to relieve skin inflammation and itch caused by skin conditions such as eczema, psoriasis and dermatitis. The affected lot was distributed to pharmacies in Canada between November 24, 2022 and March 22, 2023.

Health Canada is monitoring the company's recall, and its implementation of any necessary corrective and preventative actions to prevent this issue from reoccurring.

What you should do

• Do not use the affected product. Consult a health care professional if you have used this product and have health concerns.
• Return the products to your local pharmacy for proper disposal.
• Contact Teva Canada Ltd. toll-free at 1-800-268-4129 if you have questions about the recall.
• Report any health product-related side effects or complaints to Health Canada.

Related links:

• Recall notice: TEVA-ECTOSONE

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SOURCE Health Canada (HC)

Media Enquiries: Health Canada, [phone], [email protected]; Public Enquiries: [phone], 1-866 225-0709, [email protected]