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.
The agency’s classification
FDA (Drugs): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
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.
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