Recalls / Class III
Class IIID-1377-2020
Product
Nystatin Oral Suspension, USP 500,000 units/5mL Cup, Delivers 5 mL, Rx Only, Manufactured by: VistaPharm, Largo, FL 33771, a) NDC 66689-037-50 (individual cup NDC: 66689-037-01); b) 66689-037-99.
- Affected lot / code info
- Lot #: a) 619800, Exp. 12/31/2020; 626200, Exp. 01/31/2021; b) 619800X,Exp. 12/31/2020; 626200X, Exp. 01/31/2021.
Why it was recalled
Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.
Recalling firm
- Firm
- VistaPharm, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7265 Ulmerton Rd, Largo, Florida 33771-4809
Distribution
- Quantity
- 380,700 cups
- Distribution pattern
- United States including Puerto Rico
Timeline
- Recall initiated
- 2020-06-23
- FDA classified
- 2020-07-08
- Posted by FDA
- 2020-07-15
- Terminated
- 2022-09-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1377-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.