The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-514-2013·Announced 2013-06-12

Ryddex G Tablets Recalled for Underdosing and Incorrect Dosage Regime

TG United, Inc. is recalling Ryddex G Tablets because they are underdosed or have an incorrect dosage regime. The recall affects 2,957 bottles distributed in five states.

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, which corresponds to a Severe severity score under the rubric, particularly given the risk of incorrect medication dosage.

Plain-English summary

TG United, Inc. is recalling 2,957 bottles of Ryddex G Tablets, Decongestant, Expectorant, 100 count bottle, OTC. The product is manufactured by Centurion Labs, LLC, located in Richland, MS, and carries NDC 23359-024-10. The specific lot affected is # 11E002 with an expiration date of 04/2013.

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 who have purchased this product should stop using it and contact the recalling firm or their healthcare provider for further instructions.

The recalled product

Product
Ryddex G Tablets, Decongestant, Expectorant, 100 count bottle, OTC, Centurion Labs, LLC 657 Hwy 40 South, Ste B, Richland, MS 39218, NDC 23359-024-10
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 (1)

  • Lot # 11E002 Exp. 04/2013.

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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