Once again, the Swiss drug company, Novartis, announced a recall of another over-the-counter drug from their plant. This year, they have recalled 2.3 million units of children’s Triaminic cough syrups and TheraFlu Warming Relief Syrups because the child-resistant caps can “fail to function properly and enable the cap to be removed by a child with a tamper-evident seal in place, posing a risk of unintentional ingestion and poisoning,” according to the Consumer Product Safety Commission (CPSC) recall.
There are 24 types of the two products included in the recall. A complete list can be found at:www.novartisOTC.com.
There have been 12 reports of children unscrewing the caps and four reports of children ingesting the product. According to the CPSC, one child required medical attention.
“The child resistant closure that is on this can come off very easily,” explains Pittsburgh Poison Control Center director Rita Mrvos.
The affected cough syrup bottles were produced at Novartis’ Lincoln, Nebraska manufacturing facility. A consumer complaint last November triggered an internal investigation that led the company to issue the recall.
The cough medications were sold at food, drug, mass merchandise and club stores nationwide between May 2010 and December 2011.
There is no problem with the medicine itself, which would be regulated by the U.S. Food and Drug Administration (FDA). The issue has to do with the child-resistant packaging.
“Anyone who’s had a little one around their house knows that at some point, the child can get into it easier than the adult can,” says Mrvos.
“We’re concerned that people get a little too overconfident in trusting these caps, when really they’re child resistant. They slow the child down, but they don’t stop them,” Mrvos adds.
These products contain the pain reliever acetaminophen and the antihistamine diphenhydramine, which are required by the Poison Packaging Act to be sealed with child-resistant packaging.
Too much acetaminophen can damage your liver, and too much diphenhydramine can be sedating and slow the breathing.
“Shelf life, you’ve got five to seven years, so there still may be product on the shelf. Particularly in a smaller store that doesn’t have the turnover that a larger store has,” warns Mrvoz.
The 183 lots of affected products went to market a year ago, so most have already been sold. For those lot numbers, click this link: http://www.novartisotc.com/recall_theraflu_triaminic.html
Consumers with these products should immediately stop using the products and contact Novartis for instructions on how to return the product for a refund.
Novartis OTC products like Slow-Fe (iron pills) and Excedrin from the troubled Lincoln, Nebraska plant went off the market for a while, prompting a brisk secondary market for brand name Excedrin.
Julie Masow, a spokeswoman for Novartis, said 97 percent of the product in question has either been used or already returned.
Manufacturing at the Lincoln, Nebraska facility was suspended in December 2011, and has yet to reopen, Masow said.
For more information, contact one of our Gacovino Lake attorneys at 1-800-246-HURT (4878).