Class II
Terminated
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
- Company
- Nephron Pharmaceuticals Corp.
- Recall Initiated
- October 2, 2013
- Posted
- October 30, 2013
- Recall Number
- D-66462-001
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 689,568 cartons
- Firm Location
- Orlando, FL, United States
Reason for Recall
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.
Distribution
Nationwide and Puerto Rico
Lot / Code Info
Lots #: A3A33A, A3A33B, A3A34A, A3A35A. A3A36A, A3A37A, A3A38A, Exp 06/15; A3A40A, A3A41A, A3A42A, Exp 07/15
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