Drug product
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.
D-1446-2012
Product summary
- Event
- Event 62604
- Status
- Terminated
- Classification
- Class II
- Quantity
- 56,028 cartons
- Official record key
drug-enforcement:D-1446-2012
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: A0654A, Exp 07/12; A0A62A, Exp 10/12
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility