Asthmanefrin Racephinephrine Inhalation Solution Recalled Due to Improper Storage
Asthmanefrin Racephinephrine Inhalation Solution is being recalled because batches were stored outside the conditions specified on the drug label. The recall affects products distributed nationwide.
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: FDA Class II recall with no reported illnesses, injuries, or deaths. The recall is due to a CGMP compliance deviation (improper storage) without documented safety incidents, qualifying it as a quality control matter rather than an active safety threat.
Plain-English summary
Asthmanefrin Racephinephrine Inhalation Solution, a bronchodilator for temporary relief of mild symptoms of intermittent asthma, is being recalled. The recall affects products distributed nationwide in the United States.
The product is being recalled due to a CGMP (good manufacturing practices) deviation: products were stored outside the conditions specified on the drug label. This storage deviation was identified by McKesson Medical-Surgical Inc., the recalling firm.
Consumers who have obtained this product should consult with their healthcare provider or pharmacist regarding whether continued use is appropriate.
The recalled product
- Product
- Asthmanefrin Racephinephrine Inhalation Solution Bronchodilator, For temporary relief of mild symptoms of intermittent asthma, Preservative Free, Sterile, For Oral Inhalation Only, 30 vials per box, Nephron Pharmaceuticals Corporation, NDC 0487-2784-01.
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug
- Affected units
- 1
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 17 recalled by Mckesson Medical-Surgical Inc. Corporate Office 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.
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