D-1377-2020 Class III Terminated
FDA drug recall D-1377-2020 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: 380,700 cups.
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
- 380,700 cups
Product Description
Nystatin Oral Suspension, USP 500,000 units/5mL Cup, Delivers 5 mL, Rx Only, Manufactured by: VistaPharm, Largo, FL 33771, a) NDC 66689-037-50 (individual cup NDC: 66689-037-01); b) 66689-037-99.
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 #: a) 619800, Exp. 12/31/2020; 626200, Exp. 01/31/2021; b) 619800X,Exp. 12/31/2020; 626200X, Exp. 01/31/2021.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1377-2020
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026