Drug Enforcement D-0230-2024

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

Status

Ongoing

Classification

Class II

Report Date

January 24, 2024

Termination Date

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Product Information

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.
Product quantity
53,268 Bottles
Reason for recall
MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.
Recall initiation reason
—
Initial firm notification
E-Mail
Distribution pattern
Nationwide.

Location & Firm

Recalling firm
Pharma Nobis LLC
Address
7400 Alumax Rd, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0230-2024
Event ID
93682
Recall initiation date
December 21, 2023
Center classification date
January 12, 2024
Code info
Lot A80553; Exp. 11/2025
More code info
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