The Recall Desk
ModerateFDA (Drugs)·D-527-2013·Announced 2013-06-12

TG United Recalls BroveX PSB DM Liquid Due to Dosage Issues

TG United, Inc. is recalling BroveX PSB DM 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, which typically involves a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The source text does not report any illnesses or injuries, and the hazard is related to dosage accuracy rather than a high-risk pathogen or structural defect.

Plain-English summary

TG United, Inc. is recalling BroveX PSB DM Liquid, an over-the-counter antihistamine and decongestant product. The recall involves 16 fl oz. bottles (NDC 58605-151-01) and 20 mL bottles (NDC 58605-151-02) manufactured for Pernix Therapeutics. The total quantity recalled is 19,728 20 mL bottles and 20,016 16 fl oz. 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 11AQ004, 11AQ005, 11AQ006, 11AQ007, 11BQ012, 11LQ003, 11LQ004, 11LQ005, and 11LQ006, with expiration dates ranging from 10/13 to 12/12.

The products were distributed in Florida, Mississippi, South Carolina, Louisiana, and Texas. Consumers should check their inventory for these specific lot numbers and expiration dates. If they have the affected product, they should stop using it and contact the manufacturer or their healthcare provider for further instructions.

The recalled product

Product
BroveX PSB DM LIQUID, Antihistamine, Decongestant, a) 16 fl oz. bottle, OTC, NDC 58605-151-01 b) 20 ml NDC 58605-151-02, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737
Manufacturer
TG United, Inc.
Category
Drug — Over-the-Counter Medication
Hazard

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 (9)

  • Lot# 11AQ004 Exp. 12/12
  • Lot# 11AQ005 Exp. 12/12
  • Lot # 11AQ006 Exp. 12/12
  • Lot# 11AQ007 Exp. 12/12
  • Lot # 11BQ012 Exp. 01/13
  • Lot# 11LQ003 Exp. 10/13
  • Lot# 11LQ004 Exp. 10/13
  • Lot# 11LQ005 Exp 10/13
  • Lot# 11LQ006 Exp. 10/2013.

Distribution

Distributed in 5 states:

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 →

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