American Regent is conducting a nationwide recall to the Retail/Hospital level of the following product: Epinephrine Injection, USP, 1:1000, 1 mL Ampules, NDC #0517-1071-25, Lot #1395, Exp Date: July 2012.
This recall has been undertaken because of discoloration and small visible particles found in some ampules. Potential 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. 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.
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 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. Its cardiac effects may be of use in restoring cardiac rhythm in cardiac arrest due to various causes, but it is not used in cardiac failure or in hemorrhagic, traumatic, or cardiogenic shock.
Epinephrine Injection, USP is used as a hemostatic agent. It is also used in treating 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; and for relaxation of uterine musculature and to inhibit uterine contractions. Epinephrine Injection can be utilized to prolong the action of intraspinal and local anesthetics.
The product was distributed to wholesalers and distributors nationwide. Hospitals, retail pharmacies, clinics, physician offices, and other healthcare facilities and providers should not use American Regent Epinephrine Injection, USP, 1:1000, 1 mL ampules with lot #1395 for patient care and should immediately quarantine any product for return.
American Regent is notifying its distributors and consumers by e-mail, facsimile, and/or overnight courier and is arranging for return of all recalled product. Consumers/distributors/retailers that have the product which is being recalled should stop use.
See the FDA Recall