Drug product
NYSTATIN ORAL SUSPENSION, USP 100,000 units per mL Contains: Alcohol 0.5% v/v (Bubblegum Flavored) 16 fl. oz. (480 mL) Manufactured by: VistaPharm, Inc. Largo FL 33771, USA NDC 66689-008-16 UPC 6668900816,
D-0019-2021
Product summary
- Firm
- VistaPharm, Inc.
- Event
- Event 86486
- Status
- Terminated
- Classification
- Class III
- Quantity
- 14,244 16 oz bottles
- Official record key
drug-enforcement:D-0019-2021
Official wording
Reason: Failed Impurties/Degradation Specifications: out of specification results for an impurity for one lot
Code information: Lots: 638800 Exp 10/21
Distribution pattern: Distributed Nationwide in the USA including Puerto Rico
Derived failure modes
-
Potency or specification failure
out of specification