Albuterol Sulfate Inhalation Solution, 0.083%, 2.5 mg/3 mL Sterile Unit-Dose Vials, 60-count (60 ...
FDA Recall #D-1446-2012 — Class II — June 22, 2011
Product Description
Albuterol Sulfate Inhalation Solution, 0.083%, 2.5 mg/3 mL Sterile Unit-Dose Vials, 60-count (60 x 3 mL Sterile Unit-Dose Vials) per carton, Rx only, Manufactured by: nephron pharmaceuticals corporation, Orlando, FL 32811, NDC 0487-9501-60.
Reason for Recall
Lack of Assurance of Sterility
Recalling Firm
Nephron Pharmaceuticals Corp. — Orlando, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
56,028 cartons
Distribution
Nationwide and Puerto Rico
Code Information
Lot #: A0654A, Exp 07/12; A0A62A, Exp 10/12
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated