Home / Recalls / VistaPharm, Inc. / D-1378-2020

D-1378-2020 Class III Terminated

Recalled by VistaPharm, Inc. — Largo, FL

Recall Details

Product Type
Drugs
Report Date
July 15, 2020
Initiation Date
June 23, 2020
Termination Date
September 28, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
14,760 bottles

Product Description

Nystatin Oral Suspension, USP 100,000 units per mL, Bubblegum Flavored, 16 fl. oz. bottle (480 mL), Shake Well Before Using, Rx Only, Manufactured by: VistaPharm, Inc., Largo, FL 33771, NDC 66689-008-16.

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 # 639000, Exp. 10/31/2021

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-0019-2021 Class III — NYSTATIN ORAL SUSPENSION, USP 100,000 units per mL Contains: Alcohol 0.5% v/v (B (September 25, 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)