Agency classClass IIOur severity:Moderate FDA (Drugs)·D-549-2014·Announced 2014-01-22

FDA Recalls Coenzyme Q-10 Capsules Due to Potential Labeling Errors

Aidapak Services is recalling Coenzyme Q-10 capsules because they may be mislabeled as other prescription or over-the-counter medications.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error (label mixup) without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Aidapak Services, LLC is voluntarily recalling specific lots of Coenzyme Q-10, 100 mg capsules. The recall was initiated because the product may be potentially mislabeled as other medications, including Aspirin EC, Aspirin, Tacrolimus, and Metoprolol Tartrate.

The recalled repacked drugs were distributed in Arizona, California, Oregon, and Washington. The source text identifies specific pedigree codes and expiration dates for the affected Coenzyme Q-10 lots, as well as the pedigree codes for the medications with which they may be confused.

Consumers who have purchased these specific lots of Coenzyme Q-10 capsules should stop using the product and contact their pharmacist or the recalling firm for instructions on how to return the medication.

The recalled product

Product: COENZYME Q-10, Capsule 100 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 37205055065
Manufacturer: Aidapak Services, LLC
Category: Drug — Over-the-Counter Supplement
Hazard: mis-labeling
Affected units: 341

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 (17)

COENZYME Q-10
Capsule
100 mg has the following codes Pedigree: AD30180_16
EXP: 5/9/2014
Pedigree: AD32325_4
Pedigree: AD37056_4
EXP: 5/10/2014
Pedigree: AD70655_11
EXP: 5/28/2014
Pedigree: W002711
EXP: 6/6/2014
Pedigree: W003871
EXP: 6/27/2014
Pedigree: W003998
EXP: 7/1/2014
Pedigree: AD68019_4
EXP: 5/28/2014.

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

See all →

Moderate
Aidapak Recalls Sennosides Tablets Due to Potential Labeling Errors
FDA (Drugs) · 2014-01-29
Moderate
Levothyroxine Sodium Tablets Recalled for Potential Labeling Mixup
FDA (Drugs) · 2014-01-29
Moderate
Aidapak Recalls Mislabeled Pantoprazole Sodium DR Tablets
FDA (Drugs) · 2014-01-29
Moderate
Aidapak Recalls Nifedipine ER Tablets Due to Potential Label Mixup
FDA (Drugs) · 2014-01-29
Moderate
Simvastatin Tablets Recalled for Potential Labeling Error
FDA (Drugs) · 2014-01-29

Same hazard · mis labeling