TG United Recalls BroveX PSE DM Due to CGMP Deviations
TG United, Inc. is recalling BroveX PSE DM bottles because they are underdosed or have an incorrect dosage regime.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric for significant injury or property damage reports or high-risk scenarios.
Plain-English summary
TG United, Inc. is recalling BroveX PSE DM, Antihistamine, Cough Suppressant, Decongestant, 100 count bottle, OTC. The product is manufactured for Pernix Therapeutics in Gonzales, LA. The recall involves 16,836 bottles distributed in Florida, Mississippi, South Carolina, Louisiana, and Texas.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the products are underdosed or have an incorrect dosage regime. Affected lots include 11A002, 11A003, 11A004, 11A005, and 11L003, all with expiration dates in December 2012 or October 2013.
Consumers should stop using the product and return it to the place of purchase for a refund or contact the recalling firm for further instructions.
The recalled product
- Product
- BroveX PSE DM, Antihistamine, Cough Suppressant, Decongestant, 100 count bottle, OTC, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737 NDC 58605-441-01
- Manufacturer
- TG United, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Lot# 11A002 Exp. 12/12
- Lot# 11A003 Exp. 12/12
- Lot # 11A004 Exp. 12/12
- Lot# 11A005 Exp. 12/12
- Lot# 11L003 Exp. 10/13.
Distribution
Part of a larger recall action
This product is one of 44 recalled by TG United, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 44 products in this recall →Related recalls
Same manufacturer · TG United, Inc.
See all →- SevereTG United Recalls Trigofen DM Drops Due to Underdosing
FDA (Drugs) · 2013-06-12
- SevereTG United Recalls Underdosed AMBI Antihistamine Nasal Decongestant Syrup
FDA (Drugs) · 2013-06-12
- ModerateTG United Recalls Underdosed AMBI Cough Suppressant and Expectorant
FDA (Drugs) · 2013-06-12
- SevereTG United Recalls Z-Dex Syrup Due to Underdosing and Incorrect Dosage
FDA (Drugs) · 2013-06-12
- ModerateTG United Recalls CPM PSE Drops Due to CGMP Deviations
FDA (Drugs) · 2013-06-12
Same hazard · underdosing
See all →- SevereBD Texium Closed System Drug Transfer Devices May Leak at Connector
FDA (Devices) · 2025-06-18
- HighBD TEXIUM Closed Male Luer Devices Recalled for Leaking Interface Risk
FDA (Devices) · 2025-06-18
- HighAlaris Pump Infusion Sets may leak at male luer connections
FDA (Devices) · 2025-06-18
- HighBD TEXIUM Closed Male Luer Drug Transfer Device Recall
FDA (Devices) · 2025-06-18
- HighBD Texium Needle-Free Syringe Recalled for Potential Leakage at Luer Interface
FDA (Devices) · 2025-06-18