RECALL: Epinephrine Injection 1:1000 Ampules Recall

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American Regent is conducting a nationwide voluntary recall of Epinephrine Injection, 1:1000, 1mL ampules (NDC #0517-1071-25; Lot #1395; Exp Date: July 2012).

American Regent is undertaking this voluntary recall of Epinephrine Injection due to discoloration and small visible particles found in some ampules of this lot. Potential adverse events after IV administration of solutions containing particulates may include disruption of blood flow within small blood vessels in the lung, localized inflammation (swelling and redness), and granuloma formation.  Muscle and adipose tissue damage may occur by the intramuscular or subcutaneous injection of solutions containing particulates.

Epinephrine Injection is indicated to relieve respiratory distress due to bronchospasm, to provide rapid relief of hypersensitivity reactions to drugs and other allergens, serum sickness, and to prolong the action of infiltration anesthetics.

For more information call (877) 788-3232 or visit www.americanregent.com.

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