D-1053-2017 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- August 9, 2017
- Initiation Date
- June 26, 2017
- Termination Date
- April 3, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9945 cases
Product Description
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
Reason for Recall
Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification.
Distribution Pattern
CA, IL, LA, NH, OH, PA, SC
Code Information
Lot #: 458300, Exp 09/2018; 462600, Exp 07/2018; 471000, Exp 10/2018; 474300, Exp 11/2018