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.
What this means for you
Illness, injury, or structural failure has been reported. 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
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