The Recall Desk
ModerateFDA (Drugs)·D-0478-2021·Announced 2021-06-02

Cardinal Health Recalls Advair HFA Inhalers Due to Temperature Excursions

Cardinal Health is recalling 297 units of Advair HFA inhalers due to intermittent temperature exposure during storage. The product was distributed in Florida, Georgia, and South Carolina.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity score when no specific injuries or illnesses are reported in the source text. The hazard is a potential quality deviation (temperature excursion) rather than a confirmed contamination or defect causing harm.

Plain-English summary

Cardinal Health Inc. is recalling 297 units of Advair HFA 45-21MCG 12GM inhalers. The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically intermittent exposure to temperature excursions during storage. The affected product is identified by the code TH4K and NDC/UPC 173071520.

The recalled inhalers were distributed in Florida, Georgia, and South Carolina. This is a Class II recall, indicating a situation that might cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance on obtaining a replacement. The recall is limited to the specific lot code TH4K.

The recalled product

Product
ADVAIR HFA 45-21MCG 12GM; NDC/UPC 173071520; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL
Manufacturer
Cardinal Health Inc.
Category
Drug — Inhaler
Hazard
Affected units
297

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • TH4K

Distribution

Distributed in 3 states:

Part of a larger recall action

This product is one of 198 recalled by Cardinal Health Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 198 products in this recall →

Related recalls

Same manufacturer · Cardinal Health Inc.

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Same hazard · temperature excursion

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