D-1446-2012 Class II Terminated

Recalled by Nephron Pharmaceuticals Corp. — Orlando, FL

Recall Details

Product Type
Drugs
Report Date
August 15, 2012
Initiation Date
June 22, 2011
Termination Date
November 15, 2012
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
56,028 cartons

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

Distribution Pattern

Nationwide and Puerto Rico

Code Information

Lot #: A0654A, Exp 07/12; A0A62A, Exp 10/12