The nationwide recall is being conducted at the retail/hospital level and involves Epinephrine Injection, USP, 1:1000, 1 mL Ampules NDC #0517-1071-25; Lot #1395, Exp Date: July 2012. No other lot or sizes of Epinephrine Injection, USP are subject to this voluntary recall. Epinephrine Injection, USP is manufactured by Luitpold Pharmaceuticals, Inc.
Potential adverse events following intravenous administration of solutions containing particulates may include problems such as 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 also occur when intramuscular or subcutaneous injection of solutions containing particulates occurs. Adverse events with intra-spinal injection for Epinephrine injections that contain particles are unknown, but may cause, at the very least, inflammation. Also, adverse events following topical ocular administration with Epinephrine solutions that contain particles is also not known, but would likely result in ocular pain or irritation.
The Precautions section of the Product Package Insert states that “Epinephrine Injection should be protected from exposure to light. Do not remove ampoules from carton until ready to use. The solution should not be used if its color is pinkish or darker than slightly yellow or if it contains a precipitate.”
Epinephrine Injection, USP is indicated for the relief of 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. Its cardiac effects may include its use in restoring cardiac rhythm in cardiac arrest for an array of causes; however, Epinephrine is not used in cardiac failure or in hemorrhagic, traumatic, or cardiogenic shock.
Epinephrine Injection, USP is also used as a hemostatic agent and in the treatment of mucosal congestion of hay fever, rhinitis, and acute sinusitis; to relieve bronchial asthmatic paroxysms; in syncope due to complete heart block or carotid sinus hypersensitivity; for symptomatic relief of serum sickness, urticaria, angioneurotic edema; for resuscitation in cardiac arrest following anesthetic accidents; in simple (open angle) glaucoma; for relaxation of uterine musculature and to inhibit uterine contractions; and to prolong the action of intraspinal and local anesthetics.
The recalled Epinephrine Injection was distributed to wholesalers and distributors nationwide. Hospitals, retail pharmacies, clinics, physician offices, and other healthcare facilities and providers are advised against using the recalled American Regent Epinephrine Injection for patient care and should immediately quarantine any product for return.
American Regent is notifying its distributors and consumers by email, fax, and/or overnight courier; is arranging for return of all recalled product; and will credit accounts for all returned, recalled Epinephrine
Injection. American Regent’s Customer Service Department can be reached, toll-free, at 1.877.788.3232, Monday through Friday, from 8:30 a.m. to 7:00 p.m., Eastern Time (ET); Professional Services can be reached at the same number, Monday through Friday, from 9:00 a.m. to 5:00 p.m. ET. Any adverse reactions should be reported to American Regent via email at email@example.com; by fax at 1.610.650.0170; or by telephone at 1.800.734.9236, Monday through Friday, from 9:00 a.m. to 5:00 p.m. ET.
Adverse reactions or quality problems experienced with the use of this product/lot may be reported to the FDA’s MedWatch Adverse Event Reporting program online, by regular mail, or by fax: Online at www.fda.gov/medwatch/report.htm; regular mail, use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm and mail to the address on the pre-addressed form; or by fax—mail the completed form—to 1.800.FDA.0178.