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May 24, 2000

Jordan Epinephrine Injection Recalled

Elk Grove Village, IL (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Jordan Pharmaceuticals Inc. is conducting a recall of Jordan Epinephrine Injection, USP, 1:1000, 1 mg/mL, 1mL ampuls, because of subpotency during stability testing.

The recalled Jordan Epinephrine Injection is a prescription sterile solution intended for subcutaneous or intramuscular administration for the treatment of respiratory distress in bronchial asthma or during severe, acute asthma attacks, severe anaphylactic reactions and shock, and cardiac arrest to restore cardiac rhythm.

FDA stated in its report that 2,167 100-ampule boxes were distributed in Pennsylvania, Mississippi and California.

Lot Numbers of 980308, 980401, 980501, 980601, 990205 and 990308 have been classified as a Class II Recall # D-349-0.

The Lot Numbers: 980402, 990307 and 990308 have been classified as a Class III Recall # D-350-0.

This ongoing recall was initiated by the company, by letter dated March 15, 2000.  This is the first public notice issued by the FDA.

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.
FDA Recall #d-349-0
NDC #58196-065-31

Notice of this product warning was sent via email to SafeMail subscribers May 24, 2000.

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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