Tri-Dex PE — Class II drug recall D-540-2013
Terminated recall by TG United, Inc., reported 2013-06-12, distributed in FL, LA, MS, SC, TX. CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
| Recall number | D-540-2013 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | TG United, Inc., Brooksville, FL, United States |
| Recall initiated | 2013-01-30 |
| Classified | 2013-06-04 |
| Reported by FDA | 2013-06-12 |
| Terminated | 2016-09-30 |
| Distributed | FL, LA, MS, SC, TX |
| Quantity | 12,198 |
| Reason classes | cgmp |
| NDC | 13811-0088-16 |
| Lot numbers | 05/13, 07/14, 09/13, 11FQ004, 11KQ001, 11KQ002, 11KQ003, 12HQ010 |
Product
Tri-Dex PE, Antihistamine, Antitussive, Nasal Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-088-16
Reason for recall
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-540-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.