Status
Terminated
Drug Enforcement D-1446-2012
Lack of Assurance of Sterility
Classification
Class II
Report Date
August 15, 2012
Termination Date
November 15, 2012
Product Information
- Product description
- 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.
- Product quantity
- 56,028 cartons
- Reason for recall
- Lack of Assurance of Sterility
- 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
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1446-2012
- Event ID
- 62604
- Recall initiation date
- June 22, 2011
- Center classification date
- August 9, 2012
- Code info
- Lot #: A0654A, Exp 07/12; A0A62A, Exp 10/12
- More code info
- —