TG United Recalls Poly Hist Forte Nasal Decongestant Due to Underdosing
TG United, Inc. is recalling Poly Hist Forte nasal decongestant tablets because they 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 recall is classified as FDA Class II, which corresponds to a Severe severity score according to the rubric for significant injury or property damage risks, or in this case, a significant deviation from dosage standards.
Plain-English summary
TG United, Inc. is recalling Poly Hist Forte, a nasal decongestant and antihistamine product, due to Current Good Manufacturing Practice (CGMP) deviations. The affected products are underdosed or have an incorrect dosage regime.
The recall involves 330,158 bulk tablets in 100-count bottles. The specific lot number is 12L005 with an expiration date of 10/14. The product was distributed in Florida, Mississippi, South Carolina, Louisiana, and Texas.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Poly Hist Forte, Nasal Decongestant, Antihistamine, 100 count bottle, OTC, Manufactured for: Poly Pharmaceuticals, Quitman, MS 39355 NDC 50991-210-01
- Manufacturer
- TG United, Inc.
- Category
- Drug — OTC Nasal Decongestant
- Affected units
- 330,158
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 (1)
- Lot# 12L005 Exp 10/14.
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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