FDA warns Framingham company on anesthetic creams
Exposure to high concentrations of local anesthetics, such as those in compounded topical anesthetic creams, can "cause grave reactions including seizures and irregular heartbeats," the FDA said; when different anesthetics are combined in one product, "each anesthetic's potential for harm is increased."
The New England Compounding Center offers to compound "Extra Strength Triple Anesthetic Cream, which contains benzocaine, lidocaine, and tetracaine, the FDA said.
Calls to the center last evening and this morning were not immediately returned.
According to the FDA, firms that do not resolve violations in FDA warning letters risk enforcement such as injunctions against continuing violations and seizure of illegal products.
(Chris Reidy, Globe staff)