TG United Recalls TL-DEX DM Cough Suppressant Due to Dosage Errors
TG United, Inc. is recalling 2,532 bottles of TL-DEX DM cough suppressant 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 agency classification is 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 tier for Class II drug recalls involving dosage errors.
Plain-English summary
TG United, Inc. is recalling 2,532 16-ounce bottles of TL-DEX DM, Cough Suppressant Decongestant, Expectorant. The product is an over-the-counter medication manufactured for Trigen Laboratories in Sayreville, New Jersey. The specific lot number is 11AQ003, and the expiration date is 12/12.
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 illnesses or injuries.
The recalled product was distributed in Florida, Mississippi, South Carolina, Louisiana, and Texas. Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for instructions on disposal or return.
The recalled product
- Product
- TL-DEX DM, Cough Suppressant Decongestant, Expectorant 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-067-16
- Manufacturer
- TG United, Inc.
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# 11AQ003 Exp 12/12.
Distribution
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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