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.

Reason: cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Code information: Lot #s: 18E016; 18E029, Exp. 05/2020; 18F004; 18F005; 18F039, Exp. 06/2020; 18G010; 18G017, Exp. 07/2020; 18H019, Exp. 08/2020; 18M008, Exp. 12/2020; 19A005, Exp. 01/2021; 19B010, Exp. 02/2021.

Distribution pattern: Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.