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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
June 6, 1998

PRODUCT
a) OTO-Care (otic), Antipyrine 810 mg/Benzocaine 210 mg, 1/2 fluid ounce bottles, used for the treatment of superficial infections of the external auditory canal complicated by inflammation caused by organisms susceptible to the action of the antimicrobial, and is also labeled to control itching;

b) OTO Care HC (Otic) Chloroxylenol USP 1 mg/Benzocaine 14 mg Hydrocortisone, USP, 10 mg 1/2 fluid ounce bottles, used to treat acute otitis media of various etiologies.

Recall #D-147/148-8.

CODE Lot numbers:
a) F-2465 EXP 6/99
b) F-2459 EXP 6/99.

MANUFACTURER Propharma, Inc., Miami, Florida.

RECALLED BY Manufacturer, by a) telephone followed by fax on April 3, 1998; b) by telephone and fax on May 4, 1998. Firm-initiated recall ongoing.

DISTRIBUTION Puerto Rico.

QUANTITY Approximately 6,760 bottles were distributed.

REASON Stability - Accelerated stability testing failures for benzocaine/hydrocortisone in OTO care HC and antipyrine/benzocaine in OTC care.

 

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.