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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 Solution USP, Sterile, 10mL with sterilized dropper, Rx only. The product is labeled as Dist. by: Falcon Pharmaceuticals, Ltd., Fort Worth, TX. Recall # D-
094-2.

CODE
Codes:
Lot Number Expiration
0C1782 7/2002
0C1783 7/2002
0C1784 7/2002
0C1785 7/2002
0C1786 8/2002
0C1787 8/2002
0C1788 8/2002
0C1789 8/2002
0F2139 10/2002.

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 (glassware defects).

VOLUME OF PRODUCT IN COMMERCE
410,154 units.

DISTRIBUTION
TX, NV and MD
.

 
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Health Professional:

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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.