Recalls / Class II
Class IID-1446-2012
Product
Albuterol Sulfate Inhalation Solution, 0.083%, 2.5 mg/3 mL Sterile Unit-Dose Vials, 60-count (60 x 3 mL Sterile Unit-Dose Vials) per carton, Rx only, Manufactured by: nephron pharmaceuticals corporation, Orlando, FL 32811, NDC 0487-9501-60.
- 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
- Lot #: A0654A, Exp 07/12; A0A62A, Exp 10/12
Why it was recalled
Lack of Assurance of Sterility
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, Orlando, Florida 32811-6475
Distribution
- Quantity
- 56,028 cartons
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2011-06-22
- FDA classified
- 2012-08-09
- Posted by FDA
- 2012-08-15
- Terminated
- 2012-11-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1446-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.