The Recall Desk
ModerateFDA (Drugs)·D-539-2013·Announced 2013-06-12

TG United Recalls TL-Hist PD Drops Due to Underdosing

TG United, Inc. is recalling 13,031 bottles of TL-Hist PD Drops because the product is underdosed or has 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 situations where use may cause temporary or medically reversible health consequences. The source text does not report any illnesses or injuries, and the hazard is a manufacturing deviation (underdosing) rather than a high-risk pathogen or structural defect.

Plain-English summary

TG United, Inc. is recalling 13,031 bottles of TL-Hist PD Drops, an over-the-counter antihistamine and nasal decongestant. The product is manufactured for Trigen Laboratories and is identified by NDC 13811-083-30. The specific lot affected is Lot# 12GQ003 with an expiration date of 06/14.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the products are underdosed or have an incorrect dosage regime. This classification is designated as Class II by the FDA.

The affected products were distributed in Florida, Mississippi, South Carolina, Louisiana, and Texas. Consumers should check their medicine cabinets for this specific product and lot number. If found, they should stop using the product and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
TL-Hist PD Drops, Antihistamine, Nasal Decongestant,1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-083-30
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 (1)

  • Lot# 12GQ003 Exp 06/14.

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 →

Related recalls

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Same hazard · underdosing

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