MAGNESIUM CITRATE Recall D-0230-2024
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.
MAGNESIUM CITRATE Recall D-0230-2024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0230-2024 |
| Event ID | 93682 |
| Brand | MAGNESIUM CITRATE |
| Generic Name | FRESKARO MAGNESIUM CITRATE ORAL SOLUTION - GRAPE |
| Manufacturer | FRESKARO MAGNESIUM CITRATE ORAL SOLUTION - GRAPE |
| Original Package? | 1 |
| Active Substance | MAGNESIUM CITRATE |
| Drug Route | ORAL |
| Distribution | Nationwide. |
| Quantity | 53,268 Bottles |
| Recall Reason | MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria. |
| Drug Classification | Class II |
| Drug Code Info | 20240124 |
| Product NDC | 82645-311 |
| Drug UPC | 0382645311100 |
| Recall Initiation Date | 20231221 |
| Report Date | 20240124 |
| Classification Date | 20240112 |
| Address | 7400 Alumax Rd Texarkana, TX 75501-0282 United States |
| Recalling Firm | Pharma Nobis LLC |
| Initial Notification | |
| Unique Ingredient Identifier | RHO26O1T9V |
| Drug Application Number | M007 |
| Structured Product Labeling (SPL ID) | 0d1c5d55-b64c-8097-e063-6394a90a25ca |
| Structured Product Labeling (SPL Set ID) | f0488c86-6c74-3987-e053-2a95a90a31b4 |
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