Racepinephrine Inhalation Solution Recalled for Improper Storage Conditions
Mckesson Medical-Surgical is recalling S2 Racepinephrine Inhalation Solution due to storage that deviated from label specifications. This Class II recall affects 23 cartons 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: This is an FDA Class II recall with no reported illnesses, hospitalizations, or injuries. The hazard is a manufacturing compliance deviation (improper storage conditions), not a confirmed contamination or ingredient defect, making it a precautionary recall.
Plain-English summary
S2 Racepinephrine Hydrochloride Inhalation Solution, a bronchodilator medication for oral inhalation, is being recalled by Mckesson Medical-Surgical Inc. The product is a sterile inhalation solution in 0.5 mL unit-of-use vials, supplied in cartons of 30.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations: products were stored outside the conditions specified on the drug label. This storage deviation may affect product quality.
The affected product was distributed nationwide in the United States. The recall involves 23 cartons.
Patients currently using this product should consult their healthcare provider for guidance. Patients with questions about this recall should contact their pharmacy or healthcare provider.
The recalled product
- Product
- S2 (RACEPINEPHRINE HYDROCHLORIDE)
- Brand
- S2
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- Affected units
- 23
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.
See all 17 products in this recall →Related recalls
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