FDA recall D-531-2013

TG United, Inc. · Class II · drug

Product

Poly-Vent IR, Poly-Vent DM Tablets, Expectorant, Nasal Decongestant, 60 count bottle, OTC, Distributed by: Poly Pharmaceuticals, Quitman, MS 39355, NDC 50991-561-60

Reason for recall

CGMP Deviations: Products are underdosed or have an incorrect dosage regime.

Distribution

FL, MS, SC, LA and TX

Key facts

Status: Terminated
Initiation date: 2013-01-30
Report date: 2013-06-12
Termination date: 2016-09-30
Voluntary/Mandated: Voluntary: Firm initiated
Location: Brooksville, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-531-2013