Phenobarbital Oral Solution, USP, 20 mg per 5 mL, Rx Only, One Pint (473 mL) bottle, NDC:16571-330-16, Manufactured by Bio-Pharm Inc., Levittown, PA 10957, Distributed by Rising Pharmaceuticals Inc., Saddle Brook, NJ 07663.
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-1365-2019