FDA Drug recall D-0348-2019
NYSTATIN Oral Suspension, USP 500,000 Units/5mL, unit dose 5ml cups, packaged in a) 50 unit dose cups (10x5ml unit dose cups per tray, 5 tr…
- FDA Drug
- Class III
- terminated
- Published 2018-12-26
On 2018-12-26 the FDA classified a Class III recall of NYSTATIN Oral Suspension, USP 500,000 Units/5mL, unit dose 5ml cups, packaged in a) 50 unit dose cups (10x5ml unit dose cups per tray, 5 tr… by Vistapharm, citing failed Impurities/Degradation Specifications:Out of specification for impurities.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0348-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2018-11-30 |
| Published | 2018-12-26 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Vistapharm |
| Distribution | US |
Product
NYSTATIN Oral Suspension, USP 500,000 Units/5mL, unit dose 5ml cups, packaged in a) 50 unit dose cups (10x5ml unit dose cups per tray, 5 trays per case) NDC 66689-037-50; b) 100 unit dose cups (10x5ml unit dose cups per tray, 10 trays per case) NDC 66689-037-99. Rx Only, Manufactured by VistaPharm, Inc. Largo, FL 33771
Reason
Failed Impurities/Degradation Specifications:Out of specification for impurities.
Identifiers
| code_info | Lots: a) 505300 Exp. Dec 2018; 522200 Exp. Apr 2019; 534400 Exp. Jul 2019; 539000 Exp. Aug 2019; 543400 Exp. Sep 201…Lots: a) 505300 Exp. Dec 2018; 522200 Exp. Apr 2019; 534400 Exp. Jul 2019; 539000 Exp. Aug 2019; 543400 Exp. Sep 2019; b) 523600, 522200X Exp. Apr 2019; 535500 Exp. Jul 2019; 540700 Exp. Aug 2019; 543300 Exp. Sep 2019; 550100 Exp. Oct 2019. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Other recalls by Vistapharm
- Aminocaproic Acid Oral Solution, 0.25 grams/mL, Rx only, packaged in 8 Fl. Oz. (236.5 mL) HDPE bottles, Manufactured for: VistaPharm, Inc.,…
FDA Drug · Class III · 2023-12-06 · Vistapharm - Mycophenolate Mofetil for Oral Suspension, USP, 200 mg/mL, Rx Only, bottle, Manufactured for: VistaPharm, Inc., Largo, FL 33771, USA, NDC#6…
FDA Drug · Class III · 2023-11-15 · Vistapharm - Sucralfate Oral Suspension, 1g per 10mL, 16 oz (414 mL) PET bottle (12 bottles per case), Rx Only, Manufactured and Distributed by: VistaPh…
FDA Drug · Class I · 2023-10-25 · Vistapharm - Sucralfate Oral Suspension 1g per 10mL, FOR ORAL ADMINISTRATION ONLY (414 mL bottle), Rx Only, Manufactured and Distributed by: VistaPharm,…
FDA Drug · Class II · 2023-09-20 · Vistapharm - Pyridostigmine Bromide Oral Solution, USP 60 mg/5 mL Delivers 5 mL, packaged in 5mL unit-dose cup, Rx only, Dist. by: VistaPharm, NDC 66689…
FDA Drug · Class II · 2022-11-02 · Vistapharm
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0348-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.