The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0388-2016·Announced 2015-12-09

Nephron Recalls Asthmanefrin Inhalation Solution Due to Discoloration

Nephron Pharmaceuticals is voluntarily recalling Asthmanefrin inhalation solution starter kits due to discoloration. The recall covers 47,754 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: The recall is classified as FDA Class II due to discoloration, a quality issue that may cause temporary or medically reversible adverse health consequences, fitting the Moderate severity criteria for low-risk contamination or labeling/quality errors without reported serious injury.

Plain-English summary

Nephron Pharmaceuticals Corp. is voluntarily recalling Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator, Starter Kit. The product consists of 10 individual foil-wrapped vials with 1 EZ Breathe Atomizer per carton. The recall was initiated because of discoloration in the product.

The recall affects 47,754 cartons of the medication, which were distributed nationwide. The specific lots involved are R4027A (expiration date 10/31/2015) and R4036A (expiration date 12/31/2015). The FDA has classified this recall as Class II, which indicates a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences.

Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for instructions on how to return or dispose of the medication. The recall was initiated by the firm on August 21, 2015, and was terminated on February 10, 2017.

The recalled product

Product
Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator, Starter Kit (Racepinephrine 11.25 mg) 10 individual foil wrapped vials with 1 EZ Breathe Atomizer per carton, Manufactured By: nephron pharmaceuticals corporation, Orlando, FL --- NDC 0487-2784-10
Manufacturer
Nephron Pharmaceuticals Corp.
Category
Drug — Inhalation Solution
Hazard
Affected units
47,754

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)

  • Lots R4027A (Exp 10/31/2015)
  • R4036A (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.

See all 2 products in this recall →

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