Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL, Rx Only, 16 FL. oz. (473 mL) bottle, NDC:13668-577-10 Distributed by 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-1384-2019