The Recall Desk
SevereFDA (Drugs)·D-531-2013·Announced 2013-06-12

TG United Recalls Poly-Vent Tablets Due to Incorrect Dosage

TG United, Inc. is recalling Poly-Vent IR and DM tablets because they are underdosed or have an incorrect dosage regime.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this recall as Class II. Per the rubric, an agency's own classification of FDA Class II mandates a minimum score of 4 (Severe), as it indicates a reasonable probability of adverse health consequences.

Plain-English summary

TG United, Inc. is recalling Poly-Vent IR and Poly-Vent DM tablets, which are over-the-counter expectorant and nasal decongestant products. The recall is due to Current Good Manufacturing Practice (CGMP) deviations, specifically that the products are underdosed or have an incorrect dosage regime.

The affected products are distributed in Florida, Mississippi, South Carolina, Louisiana, and Texas. The recall includes 978,092 bulk tablets from three specific lots: Lot# 11F003 (Exp 05/13), Lot# 11M007 (Exp 11/13), and Lot# 12J002 (Exp 08/14). The products are distributed by Poly Pharmaceuticals in Quitman, MS.

Consumers who have purchased these specific lots should stop using the medication and contact their healthcare provider or pharmacist for guidance. The FDA has classified this recall as Class II, indicating a reasonable probability that temporary or medically reversible adverse health consequences could occur.

The recalled product

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
TG United, Inc.
Category
Drug — Over-the-Counter Medication
Hazard
Affected units
978,092

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Lot# 11F003 Exp 05/13
  • Lot# 11M007 Exp 11/13
  • Lot# 12J002 Exp 08/14.

Distribution

Distributed in 5 states:

Part of a larger recall action

This product is one of 44 recalled by TG United, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 44 products in this recall →

Related recalls

Same manufacturer · TG United, Inc.

See all →

Same hazard · incorrect dosage

See all →