FDA Drug recall D-1377-2020
Nystatin Oral Suspension, USP 500,000 units/5mL Cup, Delivers 5 mL, Rx Only, Manufactured by: VistaPharm, Largo, FL 33771, a) NDC 66689-037…
- FDA Drug
- Class III
- terminated
- Published 2020-07-15
On 2020-07-15 the FDA classified a Class III recall of Nystatin Oral Suspension, USP 500,000 units/5mL Cup, Delivers 5 mL, Rx Only, Manufactured by: VistaPharm, Largo, FL 33771, a) NDC 66689-037… by Vistapharm, citing failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1377-2020 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2020-06-23 |
| Published | 2020-07-15 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Vistapharm |
| Distribution | PR |
Product
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
Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.
Identifiers
| code_info | Lot #: a) 619800, Exp. 12/31/2020; 626200, Exp. 01/31/2021; b) 619800X,Exp. 12/31/2020; 626200X, Exp. 01/31/2021. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1377-2020%22
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