Drug product
Lactulose Solution, USP, 20 g/30 mL, dose cups delivers 30 mL packaged 50-unit dose cups per case, Manufactured by VistaPharm, Inc., Largo, FL 33771, NDC 66689-038-01
D-1053-2017
Product summary
- Firm
- VistaPharm, Inc.
- Event
- Event 77638
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9945 cases
- Official record key
drug-enforcement:D-1053-2017
Official wording
Reason: Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification.
Code information: Lot #: 458300, Exp 09/2018; 462600, Exp 07/2018; 471000, Exp 10/2018; 474300, Exp 11/2018
Distribution pattern: CA, IL, LA, NH, OH, PA, SC
Derived failure modes
-
Microbial contamination
Microbial contamination