Home / Recalls / VistaPharm LLC / D-1149-2023

D-1149-2023 Class II Terminated

Recalled by VistaPharm LLC — Largo, FL

Recall Details

Product Type: Drugs
Report Date: September 20, 2023
Initiation Date: August 30, 2023
Termination Date: July 26, 2024
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 14,400 bottles

Product Description

Sucralfate Oral Suspension 1g per 10mL, FOR ORAL ADMINISTRATION ONLY (414 mL bottle), Rx Only, Manufactured and Distributed by: VistaPharm, Inc. Largo, FL 33771, NDC 66689-305-16

Reason for Recall

Superpotent/Subpotent single ingredient Drug: Out of Specification Assay results

Distribution Pattern

Distributed nationwide to 68 consignees in the U.S.

Code Information

Lot #: 921100; Exp. 02/2025

Other recalls by VistaPharm LLC

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-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)
D-1139-2017 Class III — Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL ( (August 17, 2017)