TG United Recalls Maxifed DM Due to Underdosing and Incorrect Dosage Regime
TG United, Inc. is recalling Maxifed DM tablets because they 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 the rubric defines as Severe when associated with significant injury or property damage reports, or generally for Class II drug recalls involving dosage errors that pose a risk of serious temporary or medically reversible adverse health consequences.
Plain-English summary
TG United, Inc. is recalling 2,706 bottles of Maxifed DM, Expectorant, Nasal Decongestant, 100 count bottles. The product is an over-the-counter medication manufactured for MCR American Pharmaceuticals Inc. The recall covers specific lots with expiration dates ranging from January 2013 to February 2014.
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 indicates a potential risk of serious temporary or medically reversible adverse health consequences.
The affected products were distributed in Florida, Mississippi, South Carolina, Louisiana, and Texas. Consumers should check their medication bottles for the NDC 58605-0409-01 and the specific lot numbers listed in the recall notice. If the product matches the recalled lots, consumers should stop using it and contact their healthcare provider or the recalling firm for instructions on disposal or replacement.
The recalled product
- Product
- Maxifed DM, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: MCR American Pharmaceuticals Inc. , Brooksville, FL 34604, NDC 58605-0409-01
- 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 (6)
- Lot# 11B002 Exp. 01/13
- Lot# 11B003 Exp. 01/13
- Lot # 11G007 Exp. 06/13
- Lot# 11J002 Exp. 08/13
- Lot# 11K002 Exp. 09/13
- Lot# 12C011 Exp. 02/14.
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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