Poly-Vent IR (TG United) – Dosage Deviation (2013)
Class II: 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
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
TG United, Inc.
Lot Codes / Batch Numbers
Lot# 11F003 Exp 05/13, Lot# 11M007 Exp 11/13, Lot# 12J002 Exp 08/14.
Products Sold
Lot# 11F003 Exp 05/13; Lot# 11M007 Exp 11/13; Lot# 12J002 Exp 08/14.
TG United, Inc. is recalling Poly-Vent IR, Poly-Vent DM Tablets, Expectorant, Nasal Decongestant, 60 count bottle, OTC, Distribut due to CGMP Deviations: Products are underdosed or have an incorrect dosage regime.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
FL, LA, MS, SC, TX
Page updated: Jan 7, 2026