Nephron Recalls Asthmanefrin Racepinephrine Inhalation Solution Due to Discoloration
Nephron Pharmaceuticals is recalling 32,490 cartons of Asthmanefrin Racepinephrine Inhalation Solution due to discoloration. The FDA classifies this as a Class II recall.
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, which typically involves a remote possibility of serious adverse health consequences. The specific defect is discoloration, which is a quality issue rather than a direct contamination or structural failure, fitting the Moderate severity criteria for minor labeling or quality errors.
Plain-English summary
Nephron Pharmaceuticals Corp. is voluntarily recalling 32,490 cartons of Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator Refills. The product consists of 30 individual foil-wrapped vials per carton containing Racepinephrine USP 11.25 mg. The recall was initiated on August 21, 2015, and is classified as Class II by the FDA.
The reason for the recall is discoloration of the product. The affected lots are R4016A (Expiration 08/31/2015), R4017A (Expiration 08/31/2015), and R4035A (Expiration 12/31/2015). The product was distributed nationwide.
Consumers should check their medication for the specific lot numbers and expiration dates listed above. If the product matches the recalled lots, they should stop using it and contact their healthcare provider or the recalling firm for instructions on disposal or replacement.
The recalled product
- Product
- Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator Refills (Racepinephrine USP 11.25 mg), 30 individual foil wrapped vials per carton, Manufactured By: nephron pharmaceuticals corporation, Orlando, FL --- NDC 0487-2784-01
- Manufacturer
- Nephron Pharmaceuticals Corp.
- Category
- Drug — Inhalation Solution
- Hazard
- Affected units
- 32,490
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 (3)
- Lots R4016A (Exp 08/31/2015)
- R4017A (Exp 08/31/2015)
- R4035A (Exp 12/31/2015)
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Nephron Pharmaceuticals Corp. 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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