|FOOD AND DRUG
FOR IMMEDIATE RELEASE
Consumer Media: 888-Info-FDA
August 12, 1998
Hydrocortisone 10 mg (1%) and Acetic Acid 20 mg (2%)Otic Solution USP, 10 mL size, Rx,
Sterile, otic solution for treatment of infections of the external auditory canal. NDC
#24208-319-10. Recall #D-218-8.
Lot Number Expiration Dates
Bausch and Lomb Pharmaceuticals, Inc., Tampa, Florida.
Manufacturer, by letter on May 26, 1998. Firm-initiated recall ongoing.
33,643 bottles were distributed; firm estimated that 1,000 bottles remained on market at
time of recall initiation.
Impurity specifications may not be met during labeled shelf life.