FDAFDA · Food and drugs·Recall number D-0146-2017
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.
Published November 30, 2016 · Recall initiated: November 9, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Microbial Contamination of Non-Sterile Products: bulk solution tested positive for the presence of the bacteria, Burkholderia cepacia.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- VistaPharm, Inc.
- Distributor
- Nationwide
- Lot
- Lot No. 378300, Exp 11/16
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States