The Recall Desk
SevereFDA (Drugs)·D-544-2013·Announced 2013-06-12

TG United Recalls Z-Dex Syrup Due to Underdosing and Incorrect Dosage

TG United, Inc. is recalling 2,388 bottles of Z-Dex Syrup because the product is underdosed or has an incorrect dosage regime.

What this means for you

Illness, injury, or structural failure has been reported. 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 potential risk of adverse health consequences due to incorrect dosing.

Plain-English summary

TG United, Inc. is recalling 2,388 16-ounce bottles of Z-Dex Syrup, an over-the-counter decongestant, antitussive, and expectorant. The product was manufactured for Trigen Laboratories in Sayreville, New Jersey, and carries the NDC 13811-0002-16. The specific lot number is 11EQ004, with an expiration date of 04/13.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the affected products are underdosed or have an incorrect dosage regime. This classification indicates a potential risk of adverse health consequences, though the source text does not report specific injuries or illnesses.

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

The recalled product

Product
Z-Dex Syrup, Decongestant, Antitussive, Expectorant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0002-16
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# 11EQ004 Exp 04/13.

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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