PlainRecalls
FDA Drug Moderate Class II Terminated

ADVAIR HFA 45-21MCG 12GM; NDC/UPC 173071520; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL

Reported: June 2, 2021 Initiated: March 15, 2021 #D-0478-2021

Product Description

ADVAIR HFA 45-21MCG 12GM; NDC/UPC 173071520; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL

Reason for Recall

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Details

Recalling Firm
Cardinal Health Inc.
Units Affected
297 inhalers
Distribution
FL, GA, SC
Location
Dublin, OH

Frequently Asked Questions

What product was recalled?
ADVAIR HFA 45-21MCG 12GM; NDC/UPC 173071520; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL. Recalled by Cardinal Health Inc.. Units affected: 297 inhalers.
Why was this product recalled?
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Which agency issued this recall?
This recall was issued by the FDA Drug on June 2, 2021. Severity: Moderate. Recall number: D-0478-2021.