D-1446-2012 Class II Terminated
FDA drug recall D-1446-2012 was initiated by Nephron Pharmaceuticals Corp. on June 22, 2011 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is terminated (terminated November 15, 2012). Affected quantity: 56,028 cartons.
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