July 18, 2000Humegon Vials Recalled by
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.
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
Lot Numbers: 0990199300, 1000299300, 10103993000, 1020499300, 103599300, 1040699300, and
Organon, Inc., West Orange, New Jersey.
Manufacturer, by letter dated May 17, 2000. Firm-initiated field correction ongoing.
This is the first public notice issued by the FDA.
Nationwide and Puerto Rico.
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,
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,
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