EpiPen, Allergy Injection
EpiPen is a preloaded injection of epinephrine, also known as adrenaline, used in case of a dangerous allergic reaction called anaphylaxis that could cause death if untreated. Reuters

Generic drug manufacturer Mylan expanded the recall of its epinephrine auto-injectors to the United States after concerns that the EpiPens may not work. The recall is also applicable to other markets in North America, Europe, Asia and South America.

The products have been retailed at both civilian and military pharmacies and according to the Wright-Patterson Air Force Base in Ohio, the recall is the result of two instances where the device was reported to have malfunctioned.

Read: Mylan Recalls EpiPens Over Presence Of Defective Part

The EpiPen is widely used to treat adverse allergic reactions to some types of food and bug bites and a malfunction, where the device fails to inject the medication into the patient, can be potentially life-threatening. Mylan, however, maintains that the defects are “extremely rare.”

The company also recalled atorvastatin calcium tablets, the generic version of Lipitor, over the potential for bacterial contamination in the product. The recalled tablets include all strengths of the medication received between June 1, 2016, and April 6, 2017, the military pharmacy said.

Mylan has advised all consumers with the recalled products to return them and said they will be replaced immediately. To return the EpiPens, consumers can contact Stericycle at 877-650-3494. Additional queries can be directed to Mylan Customer Relations at 800-796-9526 or customer.service@mylan.com.

The affected products are from 13 lots distributed from December 2015 through July 2016, the U.S. Food and Drug Administration said. This includes the EpiPen Jr 2-Pak® Auto-Injectors, 0.15 mg and the EpiPen 2-Pak® Auto-Injectors, 0.3 mg with NDC numbers 49502-501-02 and 49502-500-02.

The lot numbers of the recalled products are: 5GN767, 5GN773, 5GM631, 5GM640, 6GN215, 6GN082, 6GM072, 6GM081, 6GM088, 6GM199, 6GM091, 6GM198, and 6GM087. The expiration date of the EpiPens covered under the recall range from April 2017 to September 2017 and October 2017.