FDA-Drug2016-11-30Class II
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.
VistaPharm, Inc.
Hazard
Microbial Contamination of Non-Sterile Products: bulk solution tested positive for the presence of the bacteria, Burkholderia cepacia.
Sold states
Nationwide
Affected count
1497 cases
Manufactured in
7265 Ulmerton Rd, N/A, Largo, FL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0146-2017Don't want to check this manually?
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