Class II · Moderate risk Ongoing
Lactulose Solution
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Lactulose Solution
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Microbial Contamination of Non-Sterile Products: bulk solution tested positive for the presence of the bacteria, Burkholderia cepacia.
What was recalled
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.
- Recalling firm
- VistaPharm, Inc.
- NDC code
- 66689-039-01
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0146-2017
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Lactulose recalls
See all
Class II · Moderate risk Ongoing
Lactulose Solution
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk Terminated
Lactulose Solution
Reason cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk Terminated
Lactulose Solution
Reason cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk Terminated
Lactulose Solution
Reason Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification.
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