Recalls / Class II
Class IID-0231-2024
Product
Freskaro refresh & revitalize Magnesium Citrate Saline Laxative Oral Solution Cherry Flavor 10 fl. oz, Manufactured by: Pharma Lobis, 7400 Alumax Dr., Texarkana, TX 75501, NDC 82645-312-10.
- Brand name
- Magnesium Citrate
- Generic name
- Freskaro Magnesium Citrate Oral Solution - Cherry
- Active ingredient
- Magnesium Citrate
- Route
- Oral
- NDC
- 82645-312
- FDA application
- M007
- Affected lot / code info
- Lot A80622; Exp. 11/2025
Why it was recalled
MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.
Recalling firm
- Firm
- Pharma Nobis LLC
- Manufacturer
- Pharma Nobis, LLC
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 7400 Alumax Rd, N/A, Texarkana, Texas 75501-0282
Distribution
- Quantity
- 7,404 Bottles
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2023-12-21
- FDA classified
- 2024-01-12
- Posted by FDA
- 2024-01-24
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0231-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.