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SafetyAlerts
February 6, 2002

King Pharmaceuticals Has Recalled Pediotic 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 Pediotic Suspension Sterile, 7.5mL with sterilized dropper, (Neomycin and Polymyxin B Sulfates and Hydrocoritsone otic Suspension, USP) For use in ears only, Rx only.

PRODUCT
Pediotic Suspension Sterile, 7.5mL with sterilized dropper, (Neomycin and Polymyxin B Sulfates and Hydrocoritsone otic Suspension, USP) For use in ears only, Rx only, Recall # D-096-2.

CODE
Lots: 0F2247 (Exp 8/2002), 0F2248 (Exp 8/2002/),
0C1661 (Exp 8/2002/), 0G2420 (Exp 8/2002), and
0I1412 (Exp 11/2002).

RECALLING FIRM/MANUFACTURER
Recalling Firm: King Pharmaceuticals Inc., Bristol, TN, via 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
110,663 units.

DISTRIBUTION
Nationwide
.

 
Selected Recent Recalls


Health Professional:

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During 2000 there were over
1050 products recalled in the United
States for safety reasons!

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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.