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Budesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol 80/4.5 budesonide 80 mcg/formoter...

FDA Recall #D-0561-2021 — Class II — March 15, 2021

Recall #D-0561-2021 Date: March 15, 2021 Classification: Class II Status: Terminated

Product Description

Budesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol 80/4.5 budesonide 80 mcg/formoterol fumarate dihydrate 4.5 mcg Inhalation Aerosol 120 inhalations Rx only Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850, NDC 0310-7372-20

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

905 inhalers

Distribution

FL, GA, SC

Code Information

2000655C00

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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