FDAFDA · Food and drugs·Recall number D-537-2013
TL-DEX DM, Cough Suppressant Decongestant, Expectorant 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-067-16
Published June 12, 2013 · Recall initiated: January 30, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- TG United, Inc.
- Distributor
- FL, MS, SC, LA and TX
- Lot
- Lot# 11AQ003 Exp 12/12.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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