|FOOD AND DRUG
FOR IMMEDIATE RELEASE
Consumer Media: 888-Info-FDA
June 6, 1998
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
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.