The Recall Desk
ModerateFDA (Drugs)·D-1691-2012·Announced 2012-10-03

Dispensing Solutions Recalls Atrovent HFA Inhalers Due to Label Error

Dispensing Solutions, Inc. is recalling 18 Atrovent HFA inhalers because a sticker label incorrectly identifies the product as Ventolin HFA.

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 and involves a labeling error that could lead to medication confusion, fitting the criteria for moderate severity without reported injuries.

Plain-English summary

Dispensing Solutions, Inc. is recalling 18 units of Atrovent HFA Inhalation Aerosol (ipratropium bromide) 12.9 grams, 200 metered actuations. The recall involves specific lots (F23989, F22311) distributed in Indiana and Wisconsin.

The recall was initiated because a side panel sticker label applied by the company incorrectly identifies the product as Ventolin HFA 90 mcg instead of the correct product name, Atrovent HFA 12.9 grams Inhalation Aerosol. This labeling error creates a risk that patients or healthcare providers may confuse the medication with a different drug.

Consumers who have these specific inhalers should stop using them and contact their healthcare provider or pharmacist for guidance. The affected product is prescription-only and was packaged exclusively by Dispensing Solutions, Inc.

The recalled product

Product
Atrovent HFA Inhalation Aerosol, (ipratropium bromide) 12.9 grams, 200 metered actuations, Rx only, Packaged Exclusively by: Dispensing Solutions, Inc., Santa Ana, CA --- NDC 68258-8952-01, DSI product #8A0947
Affected units
18

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 (2)

  • Lot # F23989
  • F22311

Distribution

Distributed in 2 states: