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