RisperiDONE Oral Solution, USP, 1 mg/mL, Rx Only, 30 mL bottle, NDC 13668-589-06, Manufactured by Bio-Pharm Inc., Levittown PA 19057, Manufactured for Torrent Pharma Inc., Basking Ridge, NJ 07920.
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1345-2019