Nephron Recalls Albuterol Sulfate Inhalation Solution Due to Sterility Concerns
Nephron Pharmaceuticals is recalling Albuterol Sulfate Inhalation Solution because routine testing found bacterial growth exceeding allowable limits.
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 recall is classified as FDA Class II, and the hazard involves a lack of assurance of sterility in a sterile injectable/inhalation product, which poses a significant risk of serious injury or infection.
Plain-English summary
Nephron Pharmaceuticals Corporation is recalling Albuterol Sulfate Inhalation Solution, 0.083% (2.5 mg/3 mL), 25 x 3 mL Sterile Unit-Dose Vials. The recall involves 689,568 cartons distributed nationwide and in Puerto Rico. Affected lots include A3A33A, A3A33B, A3A34A, A3A35A, A3A36A, A3A37A, A3A38A (Exp 06/15) and A3A40A, A3A41A, A3A42A (Exp 07/15).
The recall was initiated after Nephron Pharmaceuticals conducted a routine periodic aseptic process simulation and discovered bacterial growth in a number of media fill vials that exceeded the allowable limit. This indicates a lack of assurance of sterility for the affected product.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on alternative treatments. The product is a prescription-only medication intended for oral inhalation.
The recalled product
- Product
- ALBUTEROL SULFATE (ALBUTEROL SULFATE)
- Brand
- ALBUTEROL SULFATE
- Manufacturer
- Nephron Pharmaceuticals Corp.
- Category
- Drug — Inhalation Solution
- Affected units
- 689,568
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 (11)
- Lots #: A3A33A
- A3A33B
- A3A34A
- A3A35A. A3A36A
- A3A37A
- A3A38A
- Exp 06/15
- A3A40A
- A3A41A
- A3A42A
- Exp 07/15
UPCs (1)
- 0304879501003
Distribution
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