American Regent Recalls Epinephrine Ampoules

American Regent, based in New York, has announced a recall of one lot of its Epinephrine Injection.

American Regent of Shirley, N.Y., voluntarily recalled one lot of Epinephrine Injection, USP, 1:1000, 1 mL AmpulesNDC, today due to discoloration and small, visible particles found in some ampoules in the lot.

The only lot affected by the recall is #1395 with an expiration date of July 2012.

Epinephrine is used for emergency therapy of cardiac arrest and anaphylactic show and is a hemostatic by virtue of its vasoconstrictive effects, according to the Merck Veterinary Manual, Tenth Edition.

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.

Ampoules from the recalled lot should be immediately quarantined for return, according to American Regent, a subsidiary of Luitpold Pharmaceuticals Inc. The company will credit accounts for all returned product from the recalled lot.

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