Teva Pharmaceuticals USA recalls Epinephrine Injection USP, 0.3 mg (Auto-Injector), 0.3 mg/ 0.3 mL pre-filled syringe, Rx Only, Manufactured for Teva Pha

Recalled May 13, 2020 · FDA recall D-1260-2020 · Teva Pharmaceuticals USA

Hazard

CGMP Deviations: Precautions taken due to Out-of-specification for trigger force for a non-marketed lot number that shares the same component. · FDA Class II

Units

600 cartons/2 auto-injector per carton

Sold at

Product was distributed to 1 wholesaler who still had all units within their possession and had not shipped or further distributed any of the product.

Description

CGMP Deviations: Precautions taken due to Out-of-specification for trigger force for a non-marketed lot number that shares the same component.

Product

Epinephrine Injection USP, 0.3 mg (Auto-Injector), 0.3 mg/ 0.3 mL pre-filled syringe, Rx Only, Manufactured for Teva Pharmaceuticals USA, Inc. North Wales, PA 19454. NDC 0093-5986-27

Manufacturer(s)

Teva Pharmaceuticals USA

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →