A voluntary recall has been issued for dozens of over-the-counter drugs for children, including Tylenol and Motrin, because they don't meet quality standards. The maker of the recalled products said on Monday that they are taking "corrective actions" at its U.S. plant after some 40 children's versions of those drugs were recalled for quality concerns.
McNeil said on Saturday that it took action as a "precautionary measure," saying that some of the products could have problems with their ingredients while others could contain "tiny particles."
On Monday, McNeil elaborated on the nature of the "tiny particles," saying they may be solidified product ingredients or manufacturing residue such as tiny metal parts. McNeil's Pennsylvania plant is the only plant that manufactures Consumer Healthcare liquid pediatric products.
She said the agency decided to push for the recall before releasing all the details of the inspection because of the "vulnerability" of the consumers of these drugs.
"These are over-the-counter drugs and they impact infants and children," she said. "So it was even more important to get the message out that there could be a potential problem."
As of Monday, she said the FDA still maintains its position that the recalled drugs pose a "remote" potential for serious health problems.
Drugs affected include children's versions of Tylenol, Tylenol Plus, Motrin, Zyrtec and Benadryl. They were made in the United States and distributed to Canada, the Dominican Republic, Dubai, Fiji, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad & Tobago and Kuwait.
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