TG United Recalls BroveX PSB Liquid Due to CGMP Deviations
TG United, Inc. is recalling BroveX PSB Liquid antihistamine and decongestant products because they are underdosed or have an incorrect dosage regime.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves underdosing or incorrect dosage regimes without reported injuries or illnesses, fitting the criteria for a moderate severity rating.
Plain-English summary
TG United, Inc. is recalling BroveX PSB Liquid, an over-the-counter antihistamine and decongestant product. The recall involves 16 fl oz. bottles (NDC 58605-150-01) and 20 ml bottles (NDC 58605-150-02) manufactured for Pernix Therapeutics. The total quantity recalled is 57,936 20 mL bottles and 7,476 16 ounce bottles.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the affected products are underdosed or have an incorrect dosage regime. The affected lots include 11CQ005 (Exp. 02/13), 11LQ002 (Exp. 10/13), 12CQ005 (Exp. 02/14), 12EQ003 (Exp. 04/14), 12EQ004 (Exp. 04/14), and 12JQ004 (Exp. 08/14).
The products were distributed in Florida, Mississippi, South Carolina, Louisiana, and Texas. Consumers should stop using the recalled products and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- BroveX PSB LIQUID, Antihistamine, Decongestant, a) 16 fl oz. bottle, OTC, NDC 58605-150-01 b) 20 ml NDC 58605-150-02, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737
- 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 (6)
- Lot# 11CQ005 Exp. 02/13
- Lot# 11LQ002 Exp. 10/13
- Lot # 12CQ005-Exp. 02/14
- Lot# 12EQ003 Exp. 04/14
- Lot# 12EQ004 Exp. 04/14
- Lot# 12JQ004 Exp. 08/14.
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