The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-516-2013·Announced 2013-06-12

TG United Recalls NoHist Tablets Due to Underdosing

TG United, Inc. is recalling NoHist Tablets because they 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 2/5 (Moderate).

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 temporary or medically reversible adverse health consequence. The specific hazard is underdosing, which is a quality deviation rather than a high-risk pathogen or structural defect, fitting the Moderate criteria for low-risk contamination or labeling/dosage errors without reported serious injury.

Plain-English summary

TG United, Inc. is recalling NoHist Tablets, an over-the-counter antihistamine and nasal decongestant product. The recall involves 4,824 bottles of the 100-count variety, identified by Lot# 11K010 and an expiration date of 09/13. The product was distributed by Larken Laboratories, Inc., in Canton, MS, and was available in Florida, Mississippi, South Carolina, Louisiana, and Texas.

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 FDA Class II.

Consumers who have purchased this specific lot of NoHist Tablets should stop using the product and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
NoHist TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Distributed by: Larken Laboratories, Inc., Canton, MS 39046, NDC 68047-173-01
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 (1)

  • Lot# 11K010 Exp. 09/13.

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 →

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