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
Reported: October 30, 2013 Initiated: October 2, 2013 #D-66462-001
Product Description
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 for Recall
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.
Details
- Recalling Firm
- Nephron Pharmaceuticals Corp.
- Units Affected
- 689,568 cartons
- Distribution
- Nationwide and Puerto Rico
- Location
- Orlando, FL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Nephron Pharmaceuticals Corp.. Units affected: 689,568 cartons.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 30, 2013. Severity: Moderate. Recall number: D-66462-001.
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