The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1446-2012·Announced 2012-08-15

Nephron Recalls Albuterol Sulfate Inhalation Solution Due to Sterility Concerns

Nephron Pharmaceuticals is recalling Albuterol Sulfate Inhalation Solution because the company cannot ensure the product is sterile. The recall affects 56,028 cartons distributed nationwide and in Puerto Rico.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source text identifies the agency classification as Class II. According to the rubric, an FDA Class II recall involving a sterile product where sterility assurance is lacking is classified as Severe (Score 4) due to the risk of significant injury or infection.

Plain-English summary

Nephron Pharmaceuticals Corp. is recalling Albuterol Sulfate Inhalation Solution, 0.083%, 2.5 mg/3 mL Sterile Unit-Dose Vials, 60-count. The recall is being conducted because the company lacks assurance of the product's sterility. The affected product is a prescription-only medication manufactured by Nephron Pharmaceuticals Corp. in Orlando, FL.

The recall covers 56,028 cartons of the medication. The specific lots affected are A0654A (expiration 07/12) and A0A62A (expiration 10/12). The product was distributed nationwide and in Puerto Rico.

Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or pharmacist for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
ALBUTEROL SULFATE (ALBUTEROL SULFATE)
Brand
ALBUTEROL SULFATE
Manufacturer
Nephron Pharmaceuticals Corp.
Category
Drug — Inhalation Solution
Hazard
Affected units
56,028

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 (4)

  • Lot #: A0654A
  • Exp 07/12
  • A0A62A
  • Exp 10/12

UPCs (1)

  • 0304879501003

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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