Recalls / Class III
Class IIID-0869-2017
Product
Nystatin Oral Suspension, USP, 100,000 units/mL, packaged in a) 2 fl.oz. (60mL) bottles (NDC 66689-008-02), and 500,000 units/5mL individual unit dose cup (NDC 66689-037-01) packaged in b) 50 count unit dose cups/case (NDC 66689-037-50) and c) 100 count unit dose cups/case (NDC 66689-037-99) Rx only, Manufactured by: VistaPharm, Largo, FL 33771.
- Affected lot / code info
- a) Lot #: 431300, Exp. 01/2018; b) Lot #: 434000, 432500, Exp. 07/2017;462200, Exp. 02/2018 c) Lot #: 443800, 445500, Exp. 09/2017; 460500, 461500, Exp. 01/2018.
Why it was recalled
Failed Impurities/Degradation Specifications: Presence of an impurity peak that exceeds approved specification.
Recalling firm
- Firm
- VistaPharm, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7265 Ulmerton Rd, Largo, Florida 33771-4809
Distribution
- Quantity
- 2,208,500 cups/18696 bottles
- Distribution pattern
- Nationwide in the US and Puerto Rico
Timeline
- Recall initiated
- 2017-05-17
- FDA classified
- 2017-05-31
- Posted by FDA
- 2017-06-07
- Terminated
- 2020-01-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0869-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.