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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
August 12, 1998

PRODUCT
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.

CODE
Lot Number   Expiration Dates
883551         6/98
903151         8/98
933511         8/98
933521         8/98

MANUFACTURER
Bausch and Lomb Pharmaceuticals, Inc., Tampa, Florida.

RECALLED BY
Manufacturer, by letter on May 26, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
33,643 bottles were distributed; firm estimated that 1,000 bottles remained on market at time of recall initiation.

REASON
Impurity specifications may not be met during labeled shelf life.

 

The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.