TG United Recalls Poly-Vent DM Tablets Due to Dosage Deviations
TG United, Inc. is recalling Poly-Vent DM Tablets because the products are underdosed or have an incorrect dosage regime.
The agency’s classification
FDA (Drugs): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, and the hazard involves incorrect dosage of a pharmaceutical product, which fits the criteria for Severe severity (FDA Class II with significant risk).
Plain-English summary
TG United, Inc. is recalling Poly-Vent DM Tablets, an over-the-counter cough suppressant, expectorant, and nasal decongestant. The recall is due to Current Good Manufacturing Practice (CGMP) deviations where the products are underdosed or have an incorrect dosage regime.
The affected product is distributed in 60-count bottles by Poly Pharmaceuticals in Quitman, MS. The recall covers 977,719 bulk tablets. Specific lots affected include Lot# 11F005 (Exp 05/13), Lot# 11M008 (Exp 11/13), and Lot# 12J003 (Exp 08/12).
The product was distributed in Florida, Mississippi, South Carolina, Louisiana, and Texas. Consumers should check their medication for these lot numbers and expiration dates. If the product matches the recalled lots, consumers should stop using it and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Poly-Vent DM Tablets, Cough Suppressant, Expectorant, Nasal Decongestant, 60 count bottle, OTC, Distributed by: Poly Pharmaceuticals, Quitman, MS 39355 NDC 50991-309-60
- Manufacturer
- TG United, Inc.
- Affected units
- 977,719
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# 11F005 Exp 05/13
- Lot# 11M008 Exp 11/13
- Lot# 12J003 Exp 08/12.
Distribution
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
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