Recalls / Class II
Class IID-913-2013
Product
Nystatin Oral Suspension, USP 500,000 units/ 5 mL (NDC 66689-037-01 ) Rx Only, Manufactured by VistaPharm, Inc. Largo, FL 33771
- Affected lot / code info
- Lot # 240200, 243000, 244800, 245600, 250800 and 253600. Exp 06/13.
Why it was recalled
Failed Impurites/Degradation Specifications: Test failure of single largest peak at 18 months.
Recalling firm
- Firm
- VistaPharm, Inc.
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 7265 Ulmerton Rd, N/A, Largo, Florida 33771-4809
Distribution
- Quantity
- 1,707,050 cups / 5ml ea.
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2013-07-04
- FDA classified
- 2013-08-21
- Posted by FDA
- 2013-08-28
- Terminated
- 2014-08-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-913-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.