Recalls / Class II
Class IID-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
- Brand name
- Bevespi Aerosphere
- Generic name
- Glycopyrrolate And Formoterol Fumarate
- Active ingredients
- Formoterol Fumarate, Glycopyrrolate
- Route
- Respiratory (inhalation)
- NDC
- 0310-4600
- FDA application
- NDA208294
- Affected lot / code info
- 6030180A00
Why it was recalled
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recalling firm
- Firm
- Cardinal Health Inc.
- Manufacturer
- AstraZeneca Pharmaceuticals LP
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7000 Cardinal Pl, N/A, Dublin, Ohio 43017-1091
Distribution
- Quantity
- 355 inhalers
- Distribution pattern
- FL, GA, SC
Timeline
- Recall initiated
- 2021-03-15
- FDA classified
- 2021-05-24
- Posted by FDA
- 2021-06-02
- Terminated
- 2024-06-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0434-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.