Nephron albuterol inhalation solution vials recalled over an illegible label
Nephron is recalling one lot of Albuterol Sulfate Inhalation Solution 0.5% unit-dose vials because of an illegible label. The action covers 146,280 vials.
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: FDA Class II recall for a labeling defect with no fault described in the product itself, which the rubric places in the minor labeling error band at Moderate.
Plain-English summary
Nephron 503B Outsourcing Facility is recalling Albuterol Sulfate Inhalation Solution, 0.5%, 25 mg/5 mL (5 mg/mL), supplied as 30 x 5 mL sterile unit-dose vials, NDC 69374-330-05. The action covers 146,280 vials.
The stated reason is a labelling issue: an illegible label. The FDA classified the action as Class II. The source does not describe any defect in the solution itself.
The affected lot is AB6001, expiry 1/15/2027. Distribution was nationwide within the United States.
This is a prescription product supplied to healthcare facilities. Facilities should check stock against the lot number above and follow the instructions issued by Nephron.
The recalled product
- Product
- Albuterol Sulfate Inhalation Solution, 0.5%, 25 mg/5 mL (5 mg/mL*), 30x5 mL Sterile Unit-Dose Vials, Rx only, nephron 503B Outsourcing facility, 4600 12th Street Extension, West Columbia, SC 29172, NDC 69374-330-05.
- Manufacturer
- Nephron SC, LLC
- Category
- Drug — Inhalation solution
- Affected units
- 146,280
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)
- Lot AB6001
- exp date 1/15/2027
Distribution
Distributed nationwide across the United States.
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