The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-545-2013·Announced 2013-06-12

TG United Recalls ZoDen DM Drops Due to Underdosing

TG United, Inc. is recalling ZoDen DM Drops because the product is underdosed or has 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, and the rubric specifies that FDA Class II recalls with significant injury/property-damage reports or structural defects are Severe. While no injuries are explicitly reported, the 'incorrect dosage regime' for a pharmaceutical product represents a significant risk of harm, aligning with the Severe classification for Class II drug recalls involving dosage errors.

Plain-English summary

TG United, Inc. is voluntarily recalling 39,801 bottles of ZoDen DM Drops, an over-the-counter antihistamine, cough suppressant, and decongestant. The recall is being conducted because the products are underdosed or have an incorrect dosage regime, which constitutes a deviation from Current Good Manufacturing Practices (CGMP).

The affected product is the 1 fl oz. (30 mL) bottle, manufactured for Trigen Laboratories. The recall includes specific lots: Lot# 11EQ009 (Exp 04/13), Lot# 12AQ004 (Exp. 12/13), and Lot# 12KQ001 (Exp. 09/14).

The recalled product was distributed in Florida, Mississippi, South Carolina, Louisiana, and Texas. Consumers who have purchased this product should stop using it and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
ZoDen DM Drops, Antihistamine,Cough Suppressant, Decongestant, , 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0080-30
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 (3)

  • Lot# 11EQ009 Exp 04/13
  • Lot# 12AQ004 Exp. 12/13
  • Lot# 12KQ001 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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