D-0019-2021 Class III Terminated
FDA drug recall D-0019-2021 was initiated by VistaPharm, Inc. on Sep 25, 2020 and is designated Class III. Reason for recall: Failed Impurties/Degradation Specifications: out of specification results for an impurity for one lot The recall status is terminated (terminated Sep 28, 2022). Affected quantity: 14,244 16 oz bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Oct 14, 2020
- Initiation Date
- Sep 25, 2020
- Termination Date
- Sep 28, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14,244 16 oz bottles
Product Description
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,
Reason for Recall
Failed Impurties/Degradation Specifications: out of specification results for an impurity for one lot
Distribution Pattern
Distributed Nationwide in the USA including Puerto Rico
Code Information
Lots: 638800 Exp 10/21
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0019-2021
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026