FDA Recall D-0230-2024
Pharma Nobis LLC · Texarkana, TX
Class II Ongoing 875 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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.
Reason for recall
MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.
Recall record
- Recall number
D-0230-2024- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Distribution
- Nationwide.
- Recall initiated
- 2023-12-21
- Classified by FDA Center
- 2024-01-12
- FDA published
- 2024-01-24
- Recalling firm
- Pharma Nobis LLC
- Firm location
- Texarkana, TX
Drug identification
- Brand name(s)
- MAGNESIUM CITRATE
- Generic name(s)
- FRESKARO MAGNESIUM CITRATE ORAL SOLUTION - GRAPE
- Manufacturer(s)
- Pharma Nobis, LLC
- NDC(s)
82645-311- Route(s)
- ORAL
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.