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Recall Observatory FDA recall evidence

Drug 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.

D-0479-2026

March 17, 2026

Class II

Product summary

Firm
Nephron SC, LLC
Event
Event 98596
Status
Ongoing
Classification
Class II
Quantity
146,280 vials
Official record key
drug-enforcement:D-0479-2026

Official wording

Reason: Labelling: Illegible label

Code information: Lot AB6001, exp date 1/15/2027

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Labelling: Illegible label