BroveX PSE (TG United) – Dosage Deviation (2013)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
BroveX PSE, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737 NDC 58605-440-01
Brand
TG United, Inc.
Lot Codes / Batch Numbers
Lot# 11A001 Exp. 12/12, Lot# 11L002 Exp. 10/13, Lot # 12K007 Exp. 09/14.
Products Sold
Lot# 11A001 Exp. 12/12; Lot# 11L002 Exp. 10/13; Lot # 12K007 Exp. 09/14.
TG United, Inc. is recalling BroveX PSE, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Pernix Thera due to CGMP Deviations: Products are underdosed or have an incorrect dosage regime.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
FL, LA, MS, SC, TX
Page updated: Jan 7, 2026