Status
Terminated
Drug Enforcement D-913-2013
Failed Impurites/Degradation Specifications: Test failure of single largest peak at 18 months.
Classification
Class II
Report Date
August 28, 2013
Termination Date
August 4, 2014
Product Information
- Product description
- Nystatin Oral Suspension, USP 500,000 units/ 5 mL (NDC 66689-037-01 ) Rx Only, Manufactured by VistaPharm, Inc. Largo, FL 33771
- Product quantity
- 1,707,050 cups / 5ml ea.
- Reason for recall
- Failed Impurites/Degradation Specifications: Test failure of single largest peak at 18 months.
- Recall initiation reason
- —
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution pattern
- Nationwide.
Location & Firm
- Recalling firm
- VistaPharm, Inc.
- Address
-
7265 Ulmerton Rd, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-913-2013
- Event ID
- 65756
- Recall initiation date
- July 4, 2013
- Center classification date
- August 21, 2013
- Code info
- Lot # 240200, 243000, 244800, 245600, 250800 and 253600. Exp 06/13.
- More code info
- —