Torrent Pharma Inc recalls Lactulose Solution, USP 10 g/15 mL, For Oral or Rectal Administration, Rx Only, 16 FL. oz. Bottle, NDC:13668-574-10, Man
Recalled June 19, 2019 · FDA recall D-1373-2019 · Torrent Pharma
Hazard
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). · FDA Class II
Units
153.540 bottles
Sold at
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Description
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Product
Lactulose Solution, USP 10 g/15 mL, For Oral or Rectal Administration, Rx Only, 16 FL. oz. Bottle, NDC:13668-574-10, Manufactured By Bio-Pharm, Levittown, PA 19057, Manufactured for Torrent Pharma Inc., Basking Ridge, NJ 07920.
Manufacturer(s)
Torrent Pharma Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →