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SafetyAlerts
May 17, 2001

Serono Inc. Recalls Crinone Progesterone Gel

Norwell, MA (SafetyAlerts) - The Food and Drug Administration (FDA) said today that Serono Inc. has recalled certain Crinone progesterone gel because of failure to meet the specifications for viscosity.

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

PRODUCT
a) Crinone 4%,(progesterone gel) [6/PACK] NDC 44087-0804-6. Recall #D-205-1.

b) Crinone 8% (Progesterone gel) NDC 44087-0818-8 [18/Pack] NDC 44087-0808-6 [6/Pack]. Recall #D-206-1.

CODES:
a) Lot Number: C0118, Expiration 10/2002;
b) Lot Numbers:   Expiration

        C00103         02/2002
        C00104         03/2002
        C00107         04/2002
        C00109         06/2002
        C00113         08/2002
        C00114         08/2002
        C00115         09/2002
        C00116         09/2002
        C00119         10/2002
        C00122         11/2003
Distributed by Serono Laboratories Randolph, MA.
NDA 20-701; NDA 20-756

MANUFACTURER:
Fleet Laboratories, Watford, England.

RECALLED BY:
Columbia Reasearch Laboratories Inc., NY Serono Inc., Norwell, MA by letter on 4/5/01. Firm-initiated recall ongoing.

DISTRIBUTION:
Nationwide.

QUANTITY:
4%=10,622 units 6%=107,674.

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.

 
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?

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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.