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Bevespi Aerosphere (glycopyrrolate and formoterol fumarate) Inhalation Aerosol 9 mcg/4.8 mcg per ...

FDA Recall #D-0434-2021 — Class II — March 15, 2021

Recall #D-0434-2021 Date: March 15, 2021 Classification: Class II Status: Terminated

Product Description

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.

Recalling Firm

Cardinal Health Inc. — Dublin, OH

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

355 inhalers

Distribution

FL, GA, SC

Code Information

6030180A00

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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