BETHESDA, MD 24 April 2012—American Regent Inc. today announced it is recalling all ampuls in epinephrine injection lot 1395 because the liquid in some containers is discolored or has small visible particles.
The company said the recall pertains only to that single lot of epinephrine 1 mg/mL in 1-mL ampuls.
American Regent markets epinephrine 1 mg/mL in 1-mL clear ampuls and 30-mL amber multiple-dose vials.
The labeling for the ampuls states that they should be protected from light and kept in the 25-unit carton "until ready to use." Another precaution in the labeling states that an ampul's solution should not be used if it is pinkish or darker than slightly yellow or if it contains a precipitate. The solution is sulfite and preservative free.
Hospitals, pharmacies, and other health care facilities are being told to immediately quarantine ampuls in lot 1395 for return. American Regent said it will credit accounts for all returned ampuls from that lot. Questions about the return or recall should be directed to the company's customer service department at 877-788-3232, 8:30 a.m. to 7 p.m. ET Monday through Friday.
According to the ASHP Drug Shortages Resource Center's bulletin on epinephrine injection, dated March 27, Hospira Inc. and JHP Pharmaceuticals have supplies of epinephrine 1 mg/mL in 1-mL ampuls or vials. These products contain a sulfite but no preservative.
The epinephrine ampuls distributed by American Regent were made by parent company Luitpold Pharmaceuticals Inc.