American Regent has issued a retail/hospital level recall of Epinephrine Injection, USP, because of discoloration and small visible particles found in some ampules of lot #1395.
The adverse events after intravenous 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, USP is indicated to relieve respiratory distress due to bronchospasm, to provide rapid relief of hypersensitivity reactions to drugs and other allergens, and to prolong the action of infiltration anesthetics.
Epinephrine Injection, USP is manufactured by Luitpold Pharmaceuticals and is distributed by American Regent.