Lactulose Solution recalled over manufacturing violations

Recall date

May 21, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Torrent Pharma Inc recalls Lactulose Solution, USP 10 g/15 mL, For Oral Administration, Rx Only, a) 16 FL. oz., NDC: 13668-580-10, b) 32 FL. oz.,…

Recall number

D-1372-2019

FDA classification

Class II

Brand / firm

Torrent Pharma Inc

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

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.