TG United Recalls Trigofen Drops Due to Underdosing and Dosage Errors
TG United, Inc. is recalling specific lots of Trigofen Drops because the products 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 source text explicitly identifies the recall as FDA Class II. According to the severity rubric, FDA Class II recalls are classified as Severe (Score 4), particularly when involving dosage errors that could impact therapeutic efficacy or safety.
Plain-English summary
TG United, Inc. is recalling 39,403 bottles of Trigofen Drops, an over-the-counter antihistamine and decongestant. The recall affects 1 fl oz (30 mL) bottles manufactured for Trigen Laboratories. The specific lots involved are 11EQ010 (expiring 04/13), 12AQ001 (expiring 12/13), and 12JQ006 (expiring 08/14).
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the affected products are underdosed or have an incorrect dosage regime. This classification is designated as FDA Class II.
The affected products were distributed in Florida, Mississippi, South Carolina, Louisiana, and Texas. Consumers should check their medication for the listed lot numbers and expiration dates. If they possess these specific products, they should stop using them and contact their healthcare provider or the recalling firm for instructions.
The recalled product
- Product
- Trigofen Drops, Antihistamine, Decongestant,1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ, 08872, NDC 13811-0081-30
- Manufacturer
- TG United, Inc.
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# 11EQ010 Exp 04/13
- Lot# 12AQ001 Exp. 12/13
- Lot# 12JQ006 Exp. 08/14.
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.
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