Drug recall D-0434-2021
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
Reason for recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Lots and codes
6030180A00
Recall details
- Recalling firm
- Cardinal Health Inc., Dublin, OH
- Quantity
- 355 inhalers
- Distribution
- FL, GA, SC
- Type
- Voluntary: Firm initiated
- Recall initiated
- March 15, 2021
- Terminated
- June 17, 2024
Related products
- Bevespi Aerosphere – drug information
- NDC 0310-4600 Bevespi Aerosphere · Glycopyrrolate 9 ug/1; Formoterol Fumarate 4.8 ug/1 · AstraZeneca Pharmaceuticals LP