FDA-Drug2013-06-12Class II
BroveX PSE DM, Antihistamine, Cough Suppressant, Decongestant, 100 count bottle, OTC, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737 NDC 58605-441-01
TG United, Inc.
Hazard
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Sold states
FL, MS, SC, LA and TX
Affected count
16,836 bottles - 100-count.
Manufactured in
16275 Aviation Loop Dr, N/A, Brooksville, FL, United States
Products
BroveX PSE DM, Antihistamine, Cough Suppressant, Decongestant, 100 count bottle, OTC, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737 NDC 58605-441-01
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-525-2013Don'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