Recalls / Class III
Class IIID-1378-2020
Product
Nystatin Oral Suspension, USP 100,000 units per mL, Bubblegum Flavored, 16 fl. oz. bottle (480 mL), Shake Well Before Using, Rx Only, Manufactured by: VistaPharm, Inc., Largo, FL 33771, NDC 66689-008-16.
- Affected lot / code info
- Lot # 639000, Exp. 10/31/2021
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
- 14,760 bottles
- 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-1378-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.