Recall: D-66462-001

Class II - Potentially Harmful

Class IIClassification

2013-10-02Initiated

TerminatedStatus

Nephron Pharmaceuticals Corp.Firm

Product

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 By: Nephron Pharmaceuticals Corporation, Orlando, FL 32811, NDC 0487-9501-25

Reason

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.

Distribution

Nationwide and Puerto Rico

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.