Drug product
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
D-0047-2024
Product summary
- Firm
- VistaPharm LLC
- Event
- Event 93096
- Status
- Terminated
- Classification
- Class I
- Quantity
- 180 bottles
- Official record key
drug-enforcement:D-0047-2024
Official wording
Reason: Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus.
Code information: Lot#: 810300, Exp 10/2023
Distribution pattern: USA Nationwide
Derived failure modes
-
Microbial contamination
Microbial Contamination