Federal Register Notice: FDA intends to take enforcement action against unapproved drug products containing carbinoxamine and persons who cause the manufacture of such products. Many products containing carbinoxamine are marketed without approved applications and many are inappropriately labeled for use in infants and young children. There is information showing that carbinoxamine should not be used in children under 2 years of age.

Any firm manufacturing such an unapproved drug product containing carbinoxamine labeled for use in children less than 2 years of age or marketed as drops for oral administration may not manufacture that product on or after 7/10. Any firm manufacturing any other such unapproved drug product containing carbinoxamine may not manufacture that product on or after 9/7. To view this notice, click here.