FDA-Drug2019-06-19Class II
Robafen AC Oral Solution (Guaifenesin and Codeine Phosphate Oral Solution, USP) 100 mg/10 mg per 5 mL, One Pint (473 mL) bottle, NDC:0904-6479-16, Distributed by Major Pharmaceuticals Inc., Livonia MI 48152.
Torrent Pharma Inc
Hazard
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Sold states
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Affected count
131,328 bottles
Manufactured in
2091 Hartel Ave, N/A, Levittown, PA, United States
Products
Robafen AC Oral Solution (Guaifenesin and Codeine Phosphate Oral Solution, USP) 100 mg/10 mg per 5 mL, One Pint (473 mL) bottle, NDC:0904-6479-16, Distributed by Major Pharmaceuticals Inc., Livonia MI 48152.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1350-2019Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief