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SafetyAlerts
November 8, 2001

York Pharmaceuticals Recalls Burn relief spray

Kansas City, KS  (SafetyAlerts) - The Food and Drug Administration (FDA) said that York Pharmaceuticals, Inc. is recalling   Burn relief spray containing Benzocaine 5.0% and Benzalkonium chloride 0.14% packaged in 3-fl. oz. containers, OTC.

This is the first public notice of this Class llI recall issued by the FDA.

RECALL NUMBER, PRODUCT AND CODE:
1. D-008-2
Burn relief spray containing Benzocaine 5.0% and Benzalkonium chloride 0.14% packaged in 3-fl. oz. containers, OTC. The product is packaged under the following labels:
a. York Burn Relief with Aloe Vera Antiseptic/Anesthetic,
Manufactured by York Pharmaceuticals, Inc., Kansas City, KS
b. Zee Burn Relief Spray with Aloe Vera, Antiseptic/
Anesthetic, Manufactured for Zee Medical, Inc., Irvine, CA
c. Medi First Plus Pain Relieving Burn Spray with Aloe Vera, Antiseptic Anesthetic, Packaged for Medi First Plus, Skokie, IL
d. Burn Relief with Aloe Vera Antiseptic, Manufactured for
First Aid Direct, Sunrise, FL
2. D-009-2
Antiseptic Spray containing Lidocaine 2.5% and Benzalkonium chloride 0.14%, packaged in 3-fl. oz. containers, OTC. The product is packaged under the following labels:
a. Zee First Aid Antiseptic Spray, Manufactured for Zee Medical, Inc., Irvine, CA
b. Medi First Plus Pain Relieving Antiseptic Spray, Packaged for Medi First Plus, Skokie, IL
c. First Aid Antiseptic, Manufactured for First Aid Direct, Sunrise, FL
d. First Aid Only Antiseptic Spray, Distributed by First Aid Only, Inc., Vancouver, WA
e. Respond First Aid Antiseptic, Distributed by Respond Industries, Inc., Denver, CO

Codes:
Burn Spray
Lot # Exp. Date Label
0001123 Jan 02 Zee Medical
0008095 Aug 02 Zee Medical
0008096 Aug 02 Zee Medical
0009013 Sep 02 Zee Medical
0010004 Oct 02 First Aid Direct, Medi First, & Zee
0010005 Oct 02 First Aid Direct & Zee Medical
0011014 Nov 02 First Aid Direct & Zee Medical
0011037 Nov 02 York, First Aid Direct, Respond & Zee
0012017 Dec 02 Zee Medical
0101045 Jan 03 Zee Medical
0103017 Mar 03 York & Zee Medical
0103078 Mar 03 York & Zee Medical
Antiseptic Spray
Lot # Exp. Date Label
0001096 Jan 02 First Aid Only
0001133 Jan 02 Zee Medical
0002031 Feb 02 Zee Medical
0002046 Feb 02 Zee Medical
0002054 Feb 02 Zee Medical
0002057 Feb 02 Zee Medical
0002089 Feb 02 Zee Medical
0002090 Feb 02 First Aid Direct, First Aid Only & Zee
0003001 Mar 02 First Aid Only
0003010 Mar 02 First Aid Only
0003065 Mar 02 First Aid Only and Respond
0003092 Mar 02 First Aid Direct, First Aid Only &
Medi First
0004041 Apr 02 First Aid Only & Zee Medical
0005022 May 02 Zee Medical
0005023 May 02 Zee Medical
0005024 May 02 First Aid Only & Zee Medical
0005100 May 02 First Aid Only
0005111 May 02 First Aid Only
0006003 Jun 02 First Aid Only & Zee Medical
0006007 Jun 02 Zee Medical
0103079 Mar 03 Zee Medical
0104038 Mar 03 Zee Medical
0105006 Mar 03 Zee Medical
0105023 Mar 03 Zee Medical

REASON:
Burn Relief Spray active ingredient Benozocaine is super-potent --Antiseptic Spray active ingredient Lidocaine is sub-potent

MANUFACTURER/RECALLING FIRM:
York Pharmaceuticals, Inc. Kansas City, KS

RECALLED BY:
Recalling firm, via letter dated 8/27/01

FIRM INITIATED RECALL:
Ongoing

DISTRIBUTION:
NY, CA, FL, CO, IL, TN, GA, and FL

QUANTITY:
Burn spray - 105,996 bottles; antiseptic spray - 247,596 btls.

 
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Health Professional:

Did you know?
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.