TG United Recalls Trigofen DM Drops Due to Underdosing
TG United, Inc. is recalling 40,149 bottles of Trigofen DM 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 recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for drug recalls involving dosage errors.
Plain-English summary
TG United, Inc. is recalling 40,149 bottles of Trigofen DM Drops, an over-the-counter antihistamine, cough suppressant, and 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 the 1 fl oz. (30 mL) bottle, NDC 13811-0082-30, manufactured for Trigen Laboratories. The recall includes specific lots: Lot# 11EQ008 (Exp 04/13), Lot# 11HQ003 (Exp. 07/13), and Lot# 12JQ007 (Exp. 08/14).
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 they have the affected product, they should stop using it and contact their healthcare provider or the recalling firm for instructions.
The recalled product
- Product
- Trigofen DM Drops, Antihistamine,Cough Suppressant, Decongestant, , 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0082-30
- 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# 11EQ008 Exp 04/13
- Lot# 11HQ003 Exp. 07/13
- Lot# 12JQ007 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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