Home / Recalls / VistaPharm, Inc. / D-0460-2017

D-0460-2017 Class II Terminated

Recalled by VistaPharm, Inc. — Largo, FL

Recall Details

Product Type: Drugs
Report Date: February 8, 2017
Initiation Date: January 18, 2017
Termination Date: August 26, 2021
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 12,059 unit dose cups

Product Description

Phenytoin Oral Suspension, USP 100 mg/ 4 mL, 50 unit dose cups of 4 mL per case., Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-036-50.

Reason for Recall

CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.

Distribution Pattern

Nationwide

Code Information

Lot No. 428700 (Exp. 11/17), 409500 (Exp. 06/17)

Other recalls by VistaPharm, Inc.

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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-1378-2020 Class III — Nystatin Oral Suspension, USP 100,000 units per mL, Bubblegum Flavored, 16 fl. o (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)