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
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
What was recalled
Lactulose Solution, USP 10 g/15 mL, For Oral Administration, Rx Only, a) 16 FL. oz., NDC: 13668-580-10, b) 32 FL. oz., NDC: 13668-580-12, Manufactured by Bio-Pharm Inc., Levittown PA 19057, Manufactured for Torrent Pharma Inc., Basking Ridge, NJ 07920.
- Recalling firm
- Torrent Pharma Inc
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1372-2019
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 Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification.
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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