Taro Pharmaceuticals Inc. is recalling one lot of Atoma-brand Diphenhydramine Hydrochloride 2% Anti-Itch Cream, due to a labelling error that may pose serious health risks to children under two.
The text printed on the tube incorrectly states that, for children under two years of age, “application should be supervised by an adult” when it should state “consult a doctor” instead.
Parents and caregivers who may use this cream on children under the age of two should be aware of the product below:
While there is no quality issue with the product, the labelling error could lead to the inappropriate use of the product on children.
The company is recalling the mislabelled products from stores, but consumers are not being asked to return products.
Health Canada recommends checking to see if your product is affected by the labelling error, and consulting a health care professional before using the affected product on children under two years of age.
If you have used this product on a child under two years old and you have concerns about their health, consult a healthcare practitioner.
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Diphenhydramine hydrochloride in a 2% concentration cream is a non-prescription antihistamine drug used to relieve itching related to, for example, insect bites, sunburns, bee stings, poison ivy, poison oak and minor skin irritation. The drug may be absorbed into the skin in a significant amount, especially if the skin is broken.
Diphenhydramine cream is not recommended for children under two years of age unless on the advice of a health care professional.
Use of diphenhydramine hydrochloride in children under two years of age can increase the risk of side effects such as restlessness, irritability or agitation, trouble sleeping, and may include more serious side effects such as muscle spasms, trouble breathing and seizures.
Products from the affected lot have been sold at retail stores across Canada since July 29, 2019.
Taro Pharmaceuticals Inc. can be reached by email at [email protected] or by calling, toll-free, 1-800-268-1975, extension 5174 or 5138, if you have questions about this recall.
Health Canada is monitoring the company’s recall and confirming that the company has taken the necessary steps to fix the labelling issue to prevent it from reoccurring. Should additional safety concerns be identified, Health Canada will take appropriate action and inform Canadians as necessary.