TG United, Inc. recalls Poly-Vent IR, Poly-Vent DM Tablets, Expectorant, Nasal Decongestant, 60 count bottle, OTC, Distributed by: Poly Pharmace
Recalled June 12, 2013 · FDA recall D-531-2013 · TG United
Hazard
CGMP Deviations: Products are underdosed or have an incorrect dosage regime. · FDA Class II
Units
978,092 Bulk Tablets
Sold at
FL, MS, SC, LA and TX
Description
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
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
Manufacturer(s)
TG United, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →