D-0230-2024 Class II Ongoing

Recalled by Pharma Nobis LLC — Texarkana, TX

FDA drug recall D-0230-2024 was initiated by Pharma Nobis LLC on Dec 21, 2023 and is designated Class II. Reason for recall: MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria. The recall status is ongoing. Affected quantity: 53,268 Bottles.

Recall Details

Product Type
Drugs
Report Date
Jan 24, 2024
Initiation Date
Dec 21, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
53,268 Bottles

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.

Distribution Pattern

Nationwide.

Code Information

Lot A80553; Exp. 11/2025

Source

Dataset
openFDA drug recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for D-0230-2024
openFDA file date
Nov 3, 2026
Loaded by RegDataLab
Nov 4, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

Source: openFDA record for D-0230-2024. Report a data issue: hello@regdatalab.com.