Status
Terminated
Drug Enforcement D-66462-001
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.
Classification
Class II
Report Date
October 30, 2013
Termination Date
August 21, 2015
Product Information
- Product description
- 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
- Product quantity
- 689,568 cartons
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution pattern
- Nationwide and Puerto Rico
Location & Firm
- Recalling firm
- Nephron Pharmaceuticals Corp.
- Address
-
4121 SW 34th St, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-66462-001
- Event ID
- 66462
- Recall initiation date
- October 2, 2013
- Center classification date
- October 18, 2013
- Code info
- Lots #: A3A33A, A3A33B, A3A34A, A3A35A. A3A36A, A3A37A, A3A38A, Exp 06/15; A3A40A, A3A41A, A3A42A, Exp 07/15
- More code info
- —