Ritedose Recalls Formoterol Fumarate Inhalation Solution Due to Impurities
The Ritedose Corporation is recalling Formoterol Fumarate Inhalation Solution because it failed impurities and degradation specifications.
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 Class II due to a failure of impurities and degradation specifications. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
The Ritedose Corporation is recalling Formoterol Fumarate Inhalation Solution, 20mcg/2mL, due to a failure of impurities and degradation specifications. The recalled product is a prescription medication packaged in cartons of 30 or 60 individually wrapped vials.
The recall involves 3,210 cartons of the medication, specifically Lot 25BL0 with an expiration date of 02/28/2027. The product was distributed nationwide within the United States.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for further instructions.
The recalled product
- Product
- FORMOTEROL FUMARATE INHALATION SOLUTION (FORMOTEROL FUMARATE DIHYDRATE)
- Brand
- FORMOTEROL FUMARATE INHALATION SOLUTION
- Manufacturer
- The Ritedose Corporation
- Category
- Drug — Inhalation Solution
- Hazard
- Affected units
- 3,210
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: 25BL0
- Expires: 02/28/2027
Distribution
Distributed nationwide across the United States.
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