The Recall Desk
ModerateFDA (Drugs)·D-0525-2021·Announced 2021-06-02

Cardinal Health Recalls Asmanex Twistero Inhalers Due to Temperature Excursions

Cardinal Health is recalling 122 Asmanex Twistero inhalers distributed in Florida, Georgia, and South Carolina due to intermittent temperature exposure during storage.

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, but the source text cites only CGMP deviations regarding temperature excursions without reporting any illnesses, injuries, or specific chemical degradation, fitting the criteria for a moderate, precautionary recall.

Plain-English summary

Cardinal Health Inc. is recalling 122 units of ASMANEX TWST 220MCG 60INH PWD (NDC/UPC 85134102). The recall is due to Current Good Manufacturing Practice (CGMP) deviations involving intermittent exposure to temperature excursions during storage.

The affected products were distributed in Florida, Georgia, and South Carolina. The specific lot code for the recalled items is T023471.

Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance on replacement or disposal.

The recalled product

Product
ASMANEX TWST 220MCG 60INH PWD; NDC/UPC 85134102; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL
Affected units
122

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)

  • T023471

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 →