Public advisory - Expanded recall: ratio-ECTOSONE (TEVA-ECTOSONE) 0.1% regular lotion and 0.05% mild lotion recalled due to an impurity that may pose health risks

OTTAWA, ON, Aug. 3, 2024 /CNW/ -

Summary

ratio-Ectosone1 (CNW Group/Health Canada (HC))

ratio-Ectosone 0.1% (CNW Group/Health Canada (HC))

• Products: ratio-ECTOSONE (TEVA-ECTOSONE) 0.1% regular lotion and 0.05% mild lotion, 60 mL (UPDATE)
• Issue: Health products – Product quality
• What to do: Do not use these products. Consult a health care professional if you have used these products and have health concerns. Return products to your local pharmacy for proper disposal.

Images

Affected products

Product	DIN	Lot	Expiry	Date added
ratio-ECTOSONE (TEVA-ECTOSONE) 0.1% regular lotion, 60 mL	00750050	686589 686592 686652 686653 687324 687325 687517 687518 688546 688547 688825 688826 690415 690416 690417 690418	8/31/2024 8/31/2024 9/30/2024 9/30/2024 1/31/2025 1/31/2025 2/28/2025 2/28/2025 9/30/2025 9/30/2025 12/31/2025 12/31/2025 12/31/2026 1/31/2027 1/31/2027 1/31/2027	2024-08-03
ratio-ECTOSONE (TEVA-ECTOSONE) 0.05% mild lotion, 60 mL	00653209	690516	1/31/2026	2024-08-03
ratio-ECTOSONE (TEVA-ECTOSONE) 0.05% mild lotion, 60 mL	00653209	688519	06/2024	2024-06-28

Issue
UPDATE – August 3, 2024:

Teva Canada Ltd. is expanding its recall to all lots of ratio-ECTOSONE (TEVA-ECTOSONE) 0.1% regular lotion and ratio-ECTOSONE (TEVA-ECTOSONE) 0.05% mild lotion after testing detected the same impurity, betamethasone enol aldehyde, above the accepted limit in some additional lots.

In addition, the products are being recalled because of labelling errors, including dosing instructions. The labels state "once or twice daily" when they should say "two to three times daily." Following the incorrect dosing instructions on the label may decrease the product's overall effectiveness in relieving skin conditions.

Original Advisory – June 28, 2024: One lot of ratio-ECTOSONE (TEVA-ECTOSONE) 0.05% mild lotion recalled due to an impurity that may pose health risks

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 products. Consult a health care professional if you have used these products 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

Également disponible en français

SOURCE Health Canada (HC)

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