Asthmanefrin Bronchodilator Medication Vials Recalled Nationwide for Short Fill
Nephron Sc Inc is recalling 387,000 vials of Asthmanefrin Racepinephrine Inhalation Solution due to short fill issues. The vials may contain insufficient solution, potentially affecting medication dosing.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This recall addresses a real manufacturing defect in a prescription respiratory medication where proper dosing is critical. Although no illnesses or injuries have been reported and the recall is voluntary, underfilled vials present a risk of harm through inadequate medication delivery.
Plain-English summary
Nephron Sc Inc is recalling 387,000 vials of Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator (NDC 0487-2784-01). The product is supplied as sterile vials containing 0.5 mL each, packaged 30 per box in foil pouches. The affected lot is Lot #126451 with expiration date April 30, 2023. Distribution includes the United States, Puerto Rico, and Guatemala.
The recall was issued because the vials contain less solution than intended due to a short fill manufacturing defect. This could potentially affect the accurate dosing of this respiratory bronchodilator medication.
Consumers who have this product should discontinue use and contact their healthcare provider, pharmacy, or Nephron Sc Inc for disposal or replacement options. The recall was voluntarily initiated by the manufacturer on January 13, 2023, and was classified as FDA Class II.
The recalled product
- Product
- Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator (racephedrine, USP 11.25), 30x0.5 mL Sterile Vials each in a foil pouch, NDC 0487-2784-01 UPC 3 04872 78401 4
- Manufacturer
- Nephron Sc Inc
- Hazard
- short-fill
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 (1)
- Lot #: 126451 Exp. 04/30/2023
Distribution
Distributed nationwide across the United States.
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