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SafetyAlerts
July 18, 2000

Humegon Vials Recalled by Organon, Inc.

West Orange, NJ (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Organon, Inc. is conducting a recall of Humegon Vial lyophilized powder because of potency failure (fish component) at stability testing - 30 degrees C.

PRODUCT
Humegon(r) Vial lyophilized powder (memotropins for injection, USP), 2 mL vial, 75 IU, Rx infertility drug. NDC #0052-0300-02.

Recall #D-417-0.  Class III

CODE
Lot Numbers: 0990199300, 1000299300, 10103993000, 1020499300, 103599300, 1040699300, and 1050799300.

MANUFACTURER
Organon, Inc., West Orange, New Jersey.

RECALLED BY
Manufacturer, by letter dated May 17, 2000. Firm-initiated field correction ongoing.   This is the first public notice issued by the FDA.

DISTRIBUTION
Nationwide and Puerto Rico.

QUANTITY
Lot # Amount Shipped
0990199300 16,796 units
1000299300 16,524 units
1010399300 16,220 units
1020499300 16,661 units
1030599300 16,638 units
1040699300 16,827 units
1050799300 11,276 units.
Note: Each unit consists of five Humegon vials and five 2 mL Sodium Chloride Injection, USP vials.

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

Notice of this product warning was sent via email to SafeMail subscribers July 18, 2000.

 
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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.