MONTREAL — A labelling error has forced Taro Pharmaceuticals Inc. to recall some of its anti-itch creams, according to Health Canada.
The error “may pose serious health risks to children under two years of age” as it incorrectly reads that “application should be supervised by an adult” when it should instead state “consult a doctor.”
The recalled product is Atoma-brand diphenhydramine hydrochloride two per cent anti-itch cream (30g, DIN: 02247560, Lot number: E9672, Expiration: April 30, 2022).
“There is no quality issue with the product, but the labelling error could lead to the inappropriate use of the product on children under two years of age,” Health Canada warns.
“The company is recalling the mislabelled products from retail stores. Consumers are not being asked to return products.”
Anyone who has this product at home is asked to consult a doctor if they have used it, as well as before using it, on a child under the age of two.
The cream is a non-prescription antihistamine drug used to relieve itching for insect bites, sunburns, bee stings, poison ivy, poison oak and minor skin irritations.
It is possible that the drug may be absorbed in significant amounts, especially if the skin is broken.
It is only recommended for children younger than two years old under the guidance of a health care professional as it can increase the risks of side effects like restlessness, irritability or agitation, trouble sleeping, or more serious side effects like muscle spasms, trouble breathing and seizures.
The products have been sold across Canada since July 29.
Contact Taro Pharmaceuticals Inc. by email (email@example.com) or phone (1-800-268-1975 ext. 5174 or 5138) if you have questions.
Health Canada says it is monitoring the company’s recall to make sure it is taking the necessary steps to fix the labelling issue to make sure it doesn’t happen again.
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