The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-523-2013·Announced 2013-06-12

TG United Recalls Maxifed-G Due to Underdosing and Incorrect Dosage

TG United, Inc. is recalling 1,623 bottles of Maxifed-G 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, and the hazard involves underdosing or incorrect dosage regimes, which poses a significant risk of therapeutic failure or adverse health consequences.

Plain-English summary

TG United, Inc. is recalling 1,623 bottles of Maxifed-G, Expectorant, Nasal Decongestant, 100 count bottle, OTC. The product is manufactured for MCR American Pharmaceuticals Inc. in Brooksville, FL, and carries the NDC 58605-0408-01.

The recall is being conducted due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the affected products are underdosed or have an incorrect dosage regime. The affected lots include Lot# 11G006 (Exp. 06/13), Lot# 11K001 (Exp. 09/13), and Lot# 12C009 (Exp. 02/14).

The affected products were distributed in Florida, Mississippi, South Carolina, Louisiana, and Texas. Consumers should stop using the recalled products and return them to the point of purchase or contact the recalling firm for further instructions.

The recalled product

Product
Maxifed-G, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: MCR American Pharmaceuticals Inc. Brooksville, FL 34604, NDC 58605-0408-01
Manufacturer
TG United, Inc.
Category
Drug — Over-the-Counter Medication
Hazard

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# 11G006 Exp. 06/13
  • Lot# 11K001 Exp. 09/13
  • Lot # 11K001 Exp. 09/13
  • Lot# 12C009 Exp. 02/14.

Distribution

Distributed in 5 states:

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 →

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