D-1052-2017 Class II Terminated
FDA drug recall D-1052-2017 was initiated by VistaPharm, Inc. on Jun 26, 2017 and is designated Class II. Reason for recall: Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification. The recall status is terminated (terminated Apr 3, 2019). Affected quantity: 6150 cases.
Recall Details
- Product Type
- Drugs
- Report Date
- Aug 9, 2017
- Initiation Date
- Jun 26, 2017
- Termination Date
- Apr 3, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6150 cases
Product Description
Lactulose Solution, USP, 10 g/15 mL, dose cups delivers 15 mL packaged in 50-unit dose cups per case, Manufactured by VistaPharm, Inc., Largo, FL 33771, NDC 66689-038-50
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 #: 468300, Exp 09/2018; 474400, Exp 11/2018
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1052-2017
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026