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Proair HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation With Dose Counter 200 Mete...

FDA Recall #D-0573-2021 — Class II — March 15, 2021

Recall #D-0573-2021 Date: March 15, 2021 Classification: Class II Status: Terminated

Product Description

Proair HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation With Dose Counter 200 Metered Inhalation 8,5 g Net Contents Rx only NDC 59310-579-22 Mktd by: Teva Respiratory, LLC Horsham, PA 19044 Mfd by: IVAX Pharmaceuticals Ireland Waterford, Ireland

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

26895 inhalers

Distribution

FL, GA, SC

Code Information

DAF02A

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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