TOPIC: Three Lots of Epinephrine Injection USP, 30 mg/ 30 mL (1 mg/mL) by American Reagent: Recall - Due to the Presence of Particulate Matter and Lack of Assurance of Sterility
AUDIENCE: Consumer, Patient, Health Care Professional, Pharmacy, Cardiology, Hematology
ISSUE: American Regent is recalling three lots of Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vials because customer complaints were received for leaking and cracked vials, resulting in lack of assurance of sterility. The firm’s investigation also revealed the presence of particulate matter identified as Nylon, Cellulosic, Acrylic, Polyethylene and Glass.
Risk Statement: Intravenous administration of Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) containing particulate matter may lead to serious adverse health consequences. Particulate matter can cause blockage and clotting in blood vessels, which can cut off blood flow to vital organs, lead to a life-threatening blood clot in the lungs (pulmonary embolism) and cause permanent organ damage or death. Additionally, these particles may cause local vein irritation, inflammatory reaction, aggravation of preexisting infections, and allergic reactions. Additionally, cracked vials can compromise the integrity of the container resulting in loss of sterility and potential contamination which can pose a serious risk for patients.
The affected Lot Numbers 25128L1C0, 25280L1C0, and 26108L1C0 were distributed nationwide, in the United States.
To date, American Regent has not received any reports of adverse events related to this recall.
For more information about this recall, click on the red button "Read Recall"below.
BACKGROUND: Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) packaged in a multi dose vials, administered intravenously, intramuscularly, or subcutaneously and is to be used by or under the direction of a physician. Epinephrine Injection, USP is indicated for the emergency treatment of allergic reactions (Type I), including anaphylaxis, which may result from insect stings or bites, foods, drugs, sera, diagnostic testing substances, and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. Epinephrine Injection, USP is also indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. Epinephrine Injection, USP is a clear, colorless, sterile solution available in a 30 mL multiple-dose vial containing 1 mg/mL.
RECOMMENDATIONS:
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Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
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Consumers and healthcare professionals with questions regarding this recall can contact American Regent Inc. using the below information. Patients that use this product which is being recalled should stop using them and contact their doctor or health care provider.
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Distributors/retailers/healthcare facilities that have the product which is being recalled should stop using and return to place of purchase or discard the product.
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