Drug product
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.
D-0230-2024
Product summary
- Firm
- Pharma Nobis LLC
- Event
- Event 93682
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 53,268 Bottles
- Official record key
drug-enforcement:D-0230-2024
Official wording
Reason: MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.
Code information: Lot A80553; Exp. 11/2025
Distribution pattern: Nationwide.
Derived failure modes
-
Microbial contamination
MICROBIAL CONTAMINATION