The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-524-2013·Announced 2013-06-12

TG United Recalls BroveX PSE Antihistamine Due to Underdosing

TG United, Inc. is recalling BroveX PSE antihistamine and nasal decongestant tablets because the products are 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 (4) under the rubric, as it involves a product that may cause temporary or medically reversible health consequences.

Plain-English summary

TG United, Inc. is recalling BroveX PSE, an over-the-counter antihistamine and nasal decongestant product. The recall involves 10,036 bottles of 100-count tablets manufactured for Pernix Therapeutics. The affected products are identified by NDC 58605-440-01 and include specific lot numbers with expiration dates ranging from December 2012 to September 2014.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the products are underdosed or have an incorrect dosage regime. This means the medication may not contain the intended amount of active ingredients or may not follow the correct dosing schedule.

The affected products were distributed in Florida, Mississippi, South Carolina, Louisiana, and Texas. Consumers who have purchased these specific lots should stop using the product and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
BroveX PSE, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737 NDC 58605-440-01
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 (3)

  • Lot# 11A001 Exp. 12/12
  • Lot# 11L002 Exp. 10/13
  • Lot # 12K007 Exp. 09/14.

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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