TG United Recalls Dallergy Chewable Tablets Due to Underdosing
TG United, Inc. is recalling Dallergy Chewable 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 recall is classified as FDA Class II, which corresponds to a 'Severe' severity score under the rubric for significant injury or health risks.
Plain-English summary
TG United, Inc. is recalling Dallergy Chewable Tablets, an over-the-counter antihistamine and nasal decongestant, due to Current Good Manufacturing Practice (CGMP) deviations. The affected products are underdosed or have an incorrect dosage regime.
The recall involves 8,296 bottles (100-count) and 153,028 bulk tablets. The specific lots affected are 12B001 (Exp. 01/14), 12B002 (Exp. 01/14), and 12F013 (Exp. 05/2014). The products were distributed in Florida, Mississippi, South Carolina, Louisiana, and Texas.
Consumers who have purchased these products should stop using them and contact the manufacturer or their healthcare provider for further instructions.
The recalled product
- Product
- Dallergy CHEWABLE TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Laser Pharmaceuticals, LLC, Greenville, SC 29615, NDC 16477-152-01
- Manufacturer
- TG United, Inc.
- Category
- Drug — OTC Antihistamine
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 (4)
- Lot# 12B001 Exp. 01/14
- Lot# 12B002 Exp 01/14
- Lot# 12F013 Exp. 05/2014
- Lot# 12F013 Exp. 05/2014.
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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