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SafetyAlerts
February 6, 2002

King Pharmaceuticals Has Recalled 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 Neomycin and Polymyxin B Sulfates and Hydrocortisone OTIC Solution USP, Sterile, 10mL with sterilized dropper, Rx only.

PRODUCT
Neomycin and Polymyxin B Sulfates and Hydrocortisone OTIC Suspension USP, Sterile, 10 mL with Sterilized Dropper, Rx only. The product is labeled as distributed by Falcon Pharmaceuticals, Ltd., Forth Worth, TX, Recall # D-095-2.

CODE
Codes:
Lot Number Expiration
0J1494 4/2003
0C1643 4/2002
0C1644 4/2002
0C1775 4/2002
0C1776 4/2002
0C1777 5/2002
0C1779 5/2002
0C1780 5/2002
0C1781 5/2002
0D1790 5/2002
0F2249 7/2002
0F2139 7/2002
0G2335 10/2002
0H2488 10/2002
0I1410 3/2003
0I1409 2/2003
0I1408 2/2003
1B1419 5/2003
1B1418 5/2003
1B1456 6/2003
1B1309 4/2003
0I1411 2/2003.

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

REASON
Lack of assurance of sterility.

VOLUME OF PRODUCT IN COMMERCE
1,164,571 units.

DISTRIBUTION
TX, NV and MD
.

 
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Health Professional:

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During 2000 there were over
1050 products recalled in the United
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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.