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SafetyAlerts
July 9, 2003

Prime Enterprises Has Recalled Coppertone

Changed 07/17/03 by FDA

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

PRODUCT
a) Coppertone_ Bug & Sun Sunscreen with Insect Repellent,
(N, N-diethyl-m-toluamide 9.5% and other isomers 0.5%),
SPF 30, Kid's Formula, 4 FL OZ (118mL) and 8 FL OZ
(237mL) bottles. Recall # D-271-3;
b) Coppertone_ Bug & Sun Sunscreen with Insect Repellent,
(N,N-diethyl-m-toluamide 9.5% and other isomers 0.5%),
SPF 30, Kid's Formula, 8 FL OZ (237mL) bottles. Recall # D-272-3.

CODE
a) 2D01PM, 2P02PM, and 3A01PM;
b) 1J01PM, 1M05PM, 1M01PM, 1M06PM, 1M05PM, 1M05APM,
1M04PM, 1N01PM, 1N06PM, 1N05PM, 1N04PM, 1N03PM,
1N02PM, 2A08PM, 2A04PM, 2A03PM, 2A02PM, 2A01PM,
2D03PM, 2E01PM, 2H01PM, 2J02PM, 2J01PM, 2K03PM,
2K02PM, 2K01PM, 2M01PM, 2N01PM, 2P01PM, 3A04PM,
3A02PM, 3B06PM, 3B01PM, 3B05PM, 3B04PM, 3B03PM,
M312005/3B06PM, M312005A, M312005B, M312105,
3C02PM, 3C01PM, and 3C03PM.

RECALLING FIRM/MANUFACTURER
Prime Enterprises, Inc., Miami Lakes, FL, by letters on May 30, 2003. Firm initiated recall is ongoing.

REASON
a) These lots contain trace quantities of an additional
sunscreen, benzophenone-4, which were incorrectly added to the formulation.
b) Certain lots of product may contain undeclared preservative.


VOLUME OF PRODUCT IN COMMERCE
902,519 units.

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!

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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.