VistaPharm, Inc.

FDA Regulatory Profile

Summary

Total Recalls
36 (1 Class I)
510(k) Clearances
0
Inspections
11
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0093-2024Class IIIMycophenolate Mofetil for Oral Suspension, USP, 200 mg/mL, Rx Only, bottle, Manufactured for: VistaPOctober 26, 2023
D-0047-2024Class ISucralfate Oral Suspension, 1g per 10mL, 16 oz (414 mL) PET bottle (12 bottles per case), Rx Only, MOctober 18, 2023
D-0126-2024Class IIIAminocaproic Acid Oral Solution, 0.25 grams/mL, Rx only, packaged in 8 Fl. Oz. (236.5 mL) HDPE bottlOctober 17, 2023
D-1149-2023Class IISucralfate Oral Suspension 1g per 10mL, FOR ORAL ADMINISTRATION ONLY (414 mL bottle), Rx Only, ManufAugust 30, 2023
D-0018-2023Class IIPyridostigmine Bromide Oral Solution, USP 60 mg/5 mL Delivers 5 mL, packaged in 5mL unit-dose cup, RSeptember 30, 2022
D-0376-2022Class IIClobazam Oral Suspension 2.5 mg/mL, 120 mL bottles, Rx only, Manufactured by: VistaPharm, Inc. LargJanuary 7, 2022
D-0019-2021Class IIINYSTATIN ORAL SUSPENSION, USP 100,000 units per mL Contains: Alcohol 0.5% v/v (Bubblegum Flavored) 1September 25, 2020
D-1378-2020Class IIINystatin Oral Suspension, USP 100,000 units per mL, Bubblegum Flavored, 16 fl. oz. bottle (480 mL), June 23, 2020
D-1377-2020Class IIINystatin Oral Suspension, USP 500,000 units/5mL Cup, Delivers 5 mL, Rx Only, Manufactured by: VistaJune 23, 2020
D-0348-2019Class IIINYSTATIN Oral Suspension, USP 500,000 Units/5mL, unit dose 5ml cups, packaged in a) 50 unit dose cupNovember 30, 2018
D-1139-2017Class IIIHydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL (Cherry Flavored), 47August 17, 2017
D-1052-2017Class IILactulose Solution, USP, 10 g/15 mL, dose cups delivers 15 mL packaged in 50-unit dose cups per caseJune 26, 2017
D-1053-2017Class IILactulose Solution, USP, 20 g/30 mL, dose cups delivers 30 mL packaged 50-unit dose cups per case, June 26, 2017
D-0869-2017Class IIINystatin Oral Suspension, USP, 100,000 units/mL, packaged in a) 2 fl.oz. (60mL) bottles (NDC 66689-0May 17, 2017
D-0465-2017Class IIMethadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II, a.) 1 fl. oz. (30 mL), 12 bottles per cJanuary 18, 2017
D-0461-2017Class IINystatin Oral Suspension, USP 500,000 Units/5 mL, a). 50 unit dose cups of 5 mL per case (NDC No. 66January 18, 2017
D-0459-2017Class IIMetoclopramide Oral Solution, USP 10 mg/ 10 mL, 50 unit dose cups of 10 mL per case, Rx only, ManufaJanuary 18, 2017
D-0458-2017Class IIHydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/325 mg per 15 mL C-II, a) 4 fl.oz .(January 18, 2017
D-0457-2017Class IINystatin Oral Suspension, USP 100,000 units per mL, a) 2 fl. oz. (60 mL), 24 bottles per case (NDC 6January 18, 2017
D-0463-2017Class IILactulose Solution, USP 10 g/15 mL, 50 unit dose cups of 15 mL per case, Rx only, Manufactured by ViJanuary 18, 2017