Agency classClass IIOur severity:Severe FDA (Drugs)·D-484-2014·Announced 2014-01-22

FDA Recalls Glucosamine/Chondroitin Tablets Due to Potential Label Mixup

Aidapak Services is recalling Glucosamine/Chondroitin DS tablets because they may be mislabeled as Docusate Sodium capsules. The error could lead to patients taking the wrong medication.

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. According to the rubric, FDA Class II recalls with potential for adverse health consequences (such as taking the wrong medication) are rated as Severe (4), especially when the agency's own classification is Class II and the hazard involves a significant risk of harm due to mislabeling.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Glucosamine/Chondroitin DS, Tablet, 500 mg/400 mg, distributed by Aidapak Services, LLC. The recall is due to a labeling error where the product may be mislabeled as Docusate Sodium, Capsule, 250 mg. The affected product has the NDC 00904559293, pedigree AD60211_17, and an expiration date of 5/22/2014.

The mislabeled product was distributed in Arizona, California, Oregon, and Washington. This labeling mixup poses a risk because patients may inadvertently take a different medication than prescribed or intended. The FDA classifies this as a Class II recall, indicating that use of or exposure to the violative product may cause temporary or medically reversible adverse health consequences.

Consumers who have this product should stop using it and contact their pharmacist or healthcare provider for guidance. They should also check their medication bottles to ensure the label matches the medication they are taking. If you have questions about this recall, you can contact Aidapak Services, LLC or the FDA.

The recalled product

Product: GLUCOSAMINE/CHONDROITIN DS, Tablet, 500 mg/400 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904559293
Manufacturer: Aidapak Services, LLC
Category: Drug — Over-The-Counter Medication
Hazard: mis-labeling
wrong-medication
Affected units: 180

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)

GLUCOSAMINE/CHONDROITIN DS
Tablet
500 mg/400 mg has the following code Pedigree: AD60211_17
EXP: 5/22/2014.

Distribution

Distributed in 4 states:

Part of a larger recall action

This product is one of 273 recalled by Aidapak Services, LLC 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 273 products in this recall →

Same manufacturer · Aidapak Services, LLC

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