Cardinal Health Inc. recalls Bevespi Aerosphere (glycopyrrolate and formoterol fumarate) Inhalation Aerosol 9 mcg/4.8 mcg per inhalation For Oral Inh
Recalled June 2, 2021 · FDA recall D-0434-2021 · Cardinal Health
Hazard
CGMP Deviations: Intermittent exposure to temperature excursion during storage. · FDA Class II
Units
355 inhalers
Sold at
FL, GA, SC
Description
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Product
Bevespi Aerosphere (glycopyrrolate and formoterol fumarate) Inhalation Aerosol 9 mcg/4.8 mcg per inhalation For Oral Inhalation only 120 inhalations Rx Only NDC 0310-4600-12 Mfd for: AstraZeneca Pharmaceuticals, LP, Wilmington, DE 19850
Manufacturer(s)
Cardinal Health Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →