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

FDA recall notice · announced August 9, 2017 · Vistapharm

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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.

Notes

Distribution: CA, IL, LA, NH, OH, PA, SC
Lot/code information: Lot #: 468300, Exp 09/2018; 474400, Exp 11/2018
Quantity: 6150 cases
Status: Terminated
Products in this recall event:
- 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)
- 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 (D-1052-2017)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.