Why it was recalled
MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot A80622; Exp. 11/2025
Where it was sold
Nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0231-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Dec 21, 2023
- FDA report date
- Jan 24, 2024
- Quantity
- 7,404 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pharma Nobis LLC
Original FDA data
Every field from FDA enforcement report D-0231-2024, exactly as published.
Show all FDA fields
- City
- Texarkana
- State
- TX
- Status
- Ongoing
- Country
- United States
- Event ID
- 93682
- Address
- 7400 Alumax Rd
- Code information
- Lot A80622; Exp. 11/2025
- Postal code
- 75501-0282
- Report date
- Jan 24, 2024
- Product type
- Drugs
- Recall number
- D-0231-2024
- Classification
- Class II
- Recalling firm
- Pharma Nobis LLC
- Product quantity
- 7,404 Bottles
- Reason for recall
- MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide.
- Recall initiation date
- Dec 21, 2023
- Initial firm notification
- Center classification date
- Jan 12, 2024