The Recall Desk
SevereFDA (Drugs)·D-528-2013·Announced 2013-06-12

TG United Recalls Lusair Liquid Due to Underdosing and Incorrect Dosage Regime

TG United, Inc. is recalling Lusair Liquid, an over-the-counter product, because it may be 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 severity score according to the rubric, as it involves a product that may cause temporary or medically reversible health consequences.

Plain-English summary

TG United, Inc. is recalling Lusair Liquid, 1 PINT bottle, OTC, marketed by Pernix Therapeutics. The recall is due to Current Good Manufacturing Practice (CGMP) deviations where the products are underdosed or have an incorrect dosage regime.

The affected lots include 11AQ004, 11AQ005, 11AQ006, 11AQ007, 11BQ012, 11LQ003, 11LQ004, 11LQ005, and 11LQ006. These products were distributed in Florida, Mississippi, South Carolina, Louisiana, and Texas.

Consumers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Lusair Liquid, 1 PINT bottle, OTC, Marketed by: Pernix Therapeutics, Gonzales, LA 70737 NDC 23359-017-16
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 (10)

  • Lot# 11AQ004 Exp. 12/12
  • Lot# 11AQ005 Exp. 12/12
  • Lot # 11AQ006 Exp. 12/12
  • Lot# 11AQ007 Exp. 12/12
  • Lot # 11BQ012 - 19728 20 mL
  • Exp. 01/13
  • Lot# 11LQ003 Exp. 10/13
  • Lot# 11LQ004 Exp. 10/13
  • Lot# 11LQ005 Exp 10/13
  • Lot# 11LQ006 Exp. 10/13.

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 →