Recalls / Class II
Class IID-66462-001
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
- Brand name
- Albuterol Sulfate
- Generic name
- Albuterol Sulfate
- Active ingredient
- Albuterol Sulfate
- Route
- Respiratory (inhalation)
- NDC
- 0487-9501
- FDA application
- ANDA074880
- Affected lot / code info
- Lots #: A3A33A, A3A33B, A3A34A, A3A35A. A3A36A, A3A37A, A3A38A, Exp 06/15; A3A40A, A3A41A, A3A42A, Exp 07/15
Why it was recalled
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.
Recalling firm
- Firm
- Nephron Pharmaceuticals Corp.
- Manufacturer
- Nephron Pharmaceuticals Corporation
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 4121 SW 34th St, N/A, Orlando, Florida 32811-6475
Distribution
- Quantity
- 689,568 cartons
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2013-10-02
- FDA classified
- 2013-10-18
- Posted by FDA
- 2013-10-30
- Terminated
- 2015-08-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-66462-001. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.