A California mother filed what appears to be the first proposed class action lawsuit since the drugmaker recalled its Triaminic cough and cold medicines over fears that children may suffer overdoses. The lawsuit, which was filed earlier this week in federal court in Los Angeles, says several studies have shown deaths and serious injuries linked to over-the-counter remedies, Reuters reports.

As a result, Novartis “either knew…or reasonably should have known that their cough and cold products were ineffective and dangerous when used by children under the age of six,” the lawsuit states, according to Reuters. A Novartis spokeswoman had no comment, but did say this is the first to bring claims involving the children’s meds. The lawsuit was brought by Kelly Carter, who last year dosed her 4-year-old son with Triaminic Daytime Cough & Cold, but it wasn’t clear whether or how the drug hurt her son. Her attorney couldn’t be reached, Reuters writes.

Last October, the Consumer Healthcare Products Association, a trade group representing OTC drugmakers, said overdoses of oral infant cough and cold medicines have led to death and serious injury in rare instances, but the group stressed that the medications are safe when used as directed. An FDA panel recommended that OTC cough and cold medicines that contain decongestants and antihistamines should come with new instructions saying they are not for very young children.