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
Check against the official notice below — it lists the full affected range.
Nephron Pharmaceuticals Corporation is recalling Albuterol Sulfate Inhalation Solution, 0.083% 2.5 mg/3 mL across the United States and Puerto Rico. The recall affects 689,568 cartons distributed under lot numbers A3A33A, A3A33B, A3A34A, A3A35A, A3A36A, A3A37A, and A3A38A with expiration dates of June 2015, and lot numbers A3A40A, A3A41A, and A3A42A with expiration dates of July 2015. The manufacturer discovered during routine testing that bacterial growth in media fill vials exceeded allowable limits, creating a lack of assurance of sterility.
The source record does not specify what remedy or action affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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 Quantity: 689,568 cartons Lot/code info: Lots #: A3A33A, A3A33B, A3A34A, A3A35A. A3A36A, A3A37A, A3A38A, Exp 06/15; A3A40A, A3A41A, A3A42A, Exp 07/15
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.