Reported Oct 30, 2013 · Terminated

Albuterol Sulfate Inhalation Solution, 0.083% 2.5 mg/3 mL for Oral Inhalation Only, Rx Only, 25 x 3 mL Sterile…

Nephron Pharmaceuticals Corp.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Nephron Pharmaceuticals Corp. · 4121 SW 34th St · Orlando, FL · 32811-6475

Is this the product you have?

  • Albuterol Sulfate Inhalation Solution, 0.083% 2.5 mg/3 mL for Oral Inhalation Only, Rx Only, 25 x 3 mL Sterile Unit-Dose Vials per carton
  • Manufactured ByNephron Pharmaceuticals Corporation, Orlando, FL 32811, NDC 0487-9501-25
Lot codes and dates
    • Lots #: A3A33A
    • A3A33B
    • A3A34A
    • A3A35A. A3A36A
    • A3A37A
    • A3A38A
    • Exp 06/15
    • A3A40A
    • A3A41A
    • A3A42A
    • Exp 07/15
Amount recalled
689,568 cartons

Where it was sold

  • Nationwide
  • PR

Why it was recalled

Lack of Assurance of Sterility: Nephron Pharmaceuticals Corporation conducted a routine periodic aseptic process simulation and discovered bacterial growth in a number of media fill vials, exceeding the allowable limit.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Aug 21, 2015 · Data as of Sep 19, 5:08 PM UTC

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