Lactulose Solution, USP, 10 g/15 mL, 15 mL unit dose cups (NDC 66689-039-01), packaged in 15 mL x 50 unit dose cups per case (NDC 66689-039-50), Rx only, Manufactured by VistaPharm, Inc., Largo, FL 33771.

FDA recall notice · announced November 30, 2016 · 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, 15 mL unit dose cups (NDC 66689-039-01), packaged in 15 mL x 50 unit dose cups per case (NDC 66689-039-50), Rx only, Manufactured by VistaPharm, Inc., Largo, FL 33771.

Reason for recall

Microbial Contamination of Non-Sterile Products: bulk solution tested positive for the presence of the bacteria, Burkholderia cepacia.

Notes

Distribution: Nationwide
Lot/code information: Lot No. 378300, Exp 11/16
Quantity: 1497 cases
Status: Terminated
Products in this recall event:
- Lactulose Solution, USP, 10 g/15 mL, 15 mL unit dose cups (NDC 66689-039-01), packaged in 15 mL x 50 unit dose cups per case (NDC 66689-039-50), Rx only, Manufactured by VistaPharm, Inc., Largo, FL 33 (D-0146-2017)

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