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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- Manufacturer
- Dispensing Solutions, Inc
- Category
- Drug — Inhalation Aerosol
- Hazard
- 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
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