Freskaro refresh & revitalize Magnesium Citrate Saline Laxative Oral Solution Grape Flavor 10 fl....

FDA Recall #D-0230-2024 — Class II — December 21, 2023

Recall #D-0230-2024 Date: December 21, 2023 Classification: Class II Status: Ongoing

Product Description

Freskaro refresh & revitalize Magnesium Citrate Saline Laxative Oral Solution Grape Flavor 10 fl. oz, Manufactured by: Pharma Lobis, 7400 Alumax Dr., Texarkana, TX 75501, NDC 82645-311-10.

Reason for Recall

MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.

Recalling Firm

Pharma Nobis LLC — Texarkana, TX

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

53,268 Bottles

Distribution

Nationwide.

Code Information

Lot A80553; Exp. 11/2025

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated