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SafetyAlerts
February 6, 2002

King Pharmaceuticals Has Recalled Cortisporin Otic Neomycin and Polymyxin B Sulfates and Hydrocortisone OTIC Solution USP

Bristol, TN (SafetyAlerts) - The Food and Drug Administration (FDA) said that King Pharmaceuticals Inc has recalled Cortisporin Otic Sterile (Neomycin and Polymyxin B Sulfates and Hydrocortisone Suspension), 10mL with sterilized dropper, For use in ears only, Rx only.

PRODUCT
Cortisporin Otic Solution Sterile(neomycin and polymyxin B sufates, and hydrocortisone otic solution,USP), 10mL with sterilized dropper, Rx only,
Recall # D-098-2.

CODE
0D1791 (Expiration 8/2002).

RECALLING FIRM/MANUFACTURER
Recalling Firm: King Pharmaceuticals Inc., Bristol, TN, by letter dated  12/18/2001.
Manufacturer: DSM Catalytica Pharmaceuticals, Greenville, NC. Firm initiated recall is ongoing.

REASON
Lack of assurance of sterility.

VOLUME OF PRODUCT IN COMMERCE
42,433 units.

DISTRIBUTION
Nationwide
.

 
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During 2000 there were over
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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.