May 15, 2020
Teva Pharmaceuticals USA issued a voluntary recall for a single lot of epinephrine injection, 0.3 mg (auto-injector), 0.3 mg/0.3 mL prefilled syringes (NDC 0093-5986-27). According to the May 13, 2020, US Food and Drug Administration (FDA) Enforcement Report, the product’s trigger force may be out of specification.
A total of 600 cartons, each containing two auto-injectors, were included in the recall. The recalled epinephrine auto-injectors were from lot 007F19AA (Exp. 4/21). The recalled products were distributed to a wholesaler that had not yet shipped or distributed the product.
Teva Pharmaceuticals initiated the recall March 5, 2020. On May 5, 2020, the FDA designated the recall Class II. Use of a product under a Class II recall could cause temporary or medically reversible adverse health consequences, or a remote possibility of serious harm.
Epinephrine auto-injectors are available with a prescription to use in emergencies to treat serious allergic reactions.