Drug 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.
D-1378-2020
Product summary
- Firm
- VistaPharm, Inc.
- Event
- Event 85888
- Status
- Terminated
- Classification
- Class III
- Quantity
- 14,760 bottles
- Official record key
drug-enforcement:D-1378-2020
Official wording
Reason: Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.
Code information: Lot # 639000, Exp. 10/31/2021
Distribution pattern: United States including Puerto Rico
Derived failure modes
-
Unknown
Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.