Drug product
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
D-66462-001
Product summary
- Event
- Event 66462
- Status
- Terminated
- Classification
- Class II
- Quantity
- 689,568 cartons
- Official record key
drug-enforcement:D-66462-001
Official wording
Reason: 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.
Code information: Lots #: A3A33A, A3A33B, A3A34A, A3A35A. A3A36A, A3A37A, A3A38A, Exp 06/15; A3A40A, A3A41A, A3A42A, Exp 07/15
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Microbial contamination
bacterial growth
-
Sterility assurance
Lack of Assurance of Sterility