Safety Alerts Saves Lives
Safety Alerts  
 
Home Privacy About Us Contact Us Change Preferences
SafetyAlerts
February 27, 2003

Pel Associates Has Recalled Skin Conditioner

 (SafetyAlerts) - The Food and Drug Administration (FDA) released the following information.

PRODUCT
a) Aerozoin,Skin Conditioner For Tape & Cast Dressings,
(Tinture of Benzoin, USP 40%), Net Wt. 3.5 oz., spray
can. Recall # D-128-3;
b) KENZOIN, Skin Conditioner For Tape & Cast Dressings,
(Tinture of Benzoin, USP 40%), Net Wt. 4 oz. (113 Grams).
Recall # D-129-3.

CODE
a) Aerozoin Lots: 1082902 Exp. 8/05; 1083002 Exp. 8/05;
1090302 Exp. 9/05; 2137 Exp. 7/05; 2137-2 Exp.7/05; 2137-3 Exp 7/05; 2137-4 Exp 7/05; 2137-5 Exp 7/05; 2137-6 Exp 7/05; 2137-7 Exp 7/05;
b) Kenzoin Lot: 2036 Exp. 2/05.

RECALLING FIRM/MANUFACTURER
Pel Associates, Inc, North Branch, NJ, by letter and fax on November 8, 2002. Firm initiated recall is ongoing.

REASON
Failure to comply with Good Manufacturing Practice Regulations including performance of finished product assays & manufacturing validation.

VOLUME OF PRODUCT IN COMMERCE
102,864 cans (Aerozoin and Kenzoin).

DISTRIBUTION
Nationwide.

 

 
Selected Recent Recalls


Health Professional:

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

How many did you hear about?

Sign-up for SafetyAlerts by Email -
The free internet newsletter that could
some day literally save your life - or
the life of someone you know.

 

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.