D-1378-2020 Class III Terminated
FDA drug recall D-1378-2020 was initiated by VistaPharm, Inc. on Jun 23, 2020 and is designated Class III. Reason for recall: Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification. The recall status is terminated (terminated Sep 28, 2022). Affected quantity: 14,760 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Jul 15, 2020
- Initiation Date
- Jun 23, 2020
- Termination Date
- Sep 28, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14,760 bottles
Product Description
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.
Reason for Recall
Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.
Distribution Pattern
United States including Puerto Rico
Code Information
Lot # 639000, Exp. 10/31/2021
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1378-2020
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026