Why it was recalled
Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus.
Product description
Sucralfate Oral Suspension, 1g per 10mL, 16 oz (414 mL) PET bottle (12 bottles per case), Rx Only, Manufactured and Distributed by: VistaPharm, Inc. Largo, FL 33771 USA, NDC 66689-305-16
Lot numbers, UPCs & expiration codes
Lot#: 810300, Exp 10/2023
Where it was sold
USA 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-0047-2024
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Oct 18, 2023
- FDA report date
- Oct 25, 2023
- Quantity
- 180 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- VistaPharm LLC
Original FDA data
Every field from FDA enforcement report D-0047-2024, exactly as published.
Show all FDA fields
- City
- Largo
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 93096
- Address
- 7265 Ulmerton Rd
- Code information
- Lot#: 810300, Exp 10/2023
- Postal code
- 33771-4809
- Report date
- Oct 25, 2023
- Product type
- Drugs
- Recall number
- D-0047-2024
- Classification
- Class I
- Recalling firm
- VistaPharm LLC
- Product quantity
- 180 bottles
- Termination date
- Apr 30, 2024
- Reason for recall
- Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Sucralfate Oral Suspension, 1g per 10mL, 16 oz (414 mL) PET bottle (12 bottles per case), Rx Only, Manufactured and Distributed by: VistaPharm, Inc. Largo, FL 33771 USA, NDC 66689-305-16
- Distribution pattern
- USA Nationwide
- Recall initiation date
- Oct 18, 2023
- Initial firm notification
- Letter
- Center classification date
- Oct 16, 2023