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Epinephrine Injections Recalled

Filed April 26th, 2012 Laurie

American Regent is conducting a voluntary recall of Epinephrine Injection at the retail/hospital level because discoloration and small visible particles were found in some ampules of the affected lot.

Intravenous administration of solutions containing particles may cause a disruption of blood flow within small vessels in the lung, resulting in localized redness and swelling and granuloma formation. Muscle and adipose tissue damage may occur by the intramuscular or subcutaneous injection of solutions containing particulates. Adverse events with intra-spinal injection for this product containing particles are unknown, but may cause inflammation. Adverse events after topical ocular administration with Epinephrine solutions containing particles are also unknown, but may result in ocular pain or irritation.

Ephinephrine is also used to regain normal cardiac rhythm.

Hospitals, emergency rooms, clinics, and other healthcare facilities and providers, or patients with questions or complaints should contact the Professional Services Department at 1-877-788-3232, Monday through Friday, from 9 a.m. to 5 p.m., ET.

Adverse reactions should be reported to American Regent via email at pv@luitpold.com, fax at 610-650-0170, or phone by at 1-800-734-9236, Monday through Friday from 9 a.m. to 5 p.m., EST.

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