Mesehist WC Recalled for Underdosing and Incorrect Dosage Regime
TG United, Inc. is recalling Mesehist WC cough and cold medicine due to CGMP deviations resulting in underdosed products or incorrect dosage regimes.
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. According to the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving significant dosage errors that could impact therapeutic efficacy or safety.
Plain-English summary
TG United, Inc. is recalling 4,884 16-ounce bottles of Mesehist WC, an over-the-counter antihistamine, antitussive, and decongestant. The product is manufactured for Trigen Laboratories. The recall involves Lot# 11DQ001 (Exp 03/13) and Lot# 11MQ010 (Exp. 11/13).
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the products are underdosed or have an incorrect dosage regime. This classification is designated as Class II by the FDA.
The affected product was distributed in Florida, Mississippi, South Carolina, Louisiana, and Texas. Consumers should stop using the product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Mesehist WC, Antihistamine, Antitussive, Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0075-16
- 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 (2)
- Lot# 11DQ001 Exp 03/13
- Lot# 11MQ010 Exp. 11/13.
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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