Home / Recalls / VistaPharm, Inc. / D-0019-2021

D-0019-2021 Class III Terminated

Recalled by VistaPharm, Inc. — Largo, FL

Recall Details

Product Type
Drugs
Report Date
October 14, 2020
Initiation Date
September 25, 2020
Termination Date
September 28, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
14,244 16 oz bottles

Product Description

NYSTATIN ORAL SUSPENSION, USP 100,000 units per mL Contains: Alcohol 0.5% v/v (Bubblegum Flavored) 16 fl. oz. (480 mL) Manufactured by: VistaPharm, Inc. Largo FL 33771, USA NDC 66689-008-16 UPC 6668900816,

Reason for Recall

Failed Impurties/Degradation Specifications: out of specification results for an impurity for one lot

Distribution Pattern

Distributed Nationwide in the USA including Puerto Rico

Code Information

Lots: 638800 Exp 10/21

Other recalls by VistaPharm, Inc.

  • D-0093-2024 Class III — Mycophenolate Mofetil for Oral Suspension, USP, 200 mg/mL, Rx Only, bottle, Manu (October 26, 2023)
  • D-0047-2024 Class I — Sucralfate Oral Suspension, 1g per 10mL, 16 oz (414 mL) PET bottle (12 bottles p (October 18, 2023)
  • D-0126-2024 Class III — Aminocaproic Acid Oral Solution, 0.25 grams/mL, Rx only, packaged in 8 Fl. Oz. ( (October 17, 2023)
  • D-1149-2023 Class II — Sucralfate Oral Suspension 1g per 10mL, FOR ORAL ADMINISTRATION ONLY (414 mL bot (August 30, 2023)
  • D-0018-2023 Class II — Pyridostigmine Bromide Oral Solution, USP 60 mg/5 mL Delivers 5 mL, packaged in (September 30, 2022)
  • D-0376-2022 Class II — Clobazam Oral Suspension 2.5 mg/mL, 120 mL bottles, Rx only, Manufactured by: V (January 7, 2022)
  • D-1378-2020 Class III — Nystatin Oral Suspension, USP 100,000 units per mL, Bubblegum Flavored, 16 fl. o (June 23, 2020)
  • D-1377-2020 Class III — Nystatin Oral Suspension, USP 500,000 units/5mL Cup, Delivers 5 mL, Rx Only, Ma (June 23, 2020)
  • D-0348-2019 Class III — NYSTATIN Oral Suspension, USP 500,000 Units/5mL, unit dose 5ml cups, packaged in (November 30, 2018)
  • D-1139-2017 Class III — Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL ( (August 17, 2017)