Agency classClass IIOur severity:Moderate FDA (Drugs)·D-541-2014·Announced 2014-01-22

Aidapak Recalls Phytonadione Tablets Due to Potential Labeling Mixup

Aidapak Services, LLC is recalling Phytonadione 5 mg tablets because they may be mislabeled as other prescription drugs. The repacked drugs were distributed in four western 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 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, but the source text does not report any illnesses or injuries, and the hazard is a labeling mixup rather than a high-risk pathogen or structural defect, fitting the criteria for a moderate severity score.

Plain-English summary

Aidapak Services, LLC is voluntarily recalling Phytonadione Tablet, 5 mg, NDC 25010040515, due to a labeling mixup. The recall involves 500-tablet units of the repacked prescription drug. The agency has classified this as a Class II recall.

The hazard is that the Phytonadione tablets may be mislabeled as other medications, including medroxyPROGESTERone ACETATE 10 mg, HYDROCORTISONE 5 mg, GALANTAMINE HBR ER 24 mg, or TORSEMIDE 10 mg. The source text does not report any illnesses or injuries associated with this labeling error.

The repacked drugs were distributed in Arizona, California, Oregon, and Washington. Specific pedigree codes and expiration dates for the affected lots are listed in the recall notice. Patients and healthcare providers should verify the labeling of their medication and contact their pharmacist or the recalling firm if they have questions.

The recalled product

Product: PHYTONADIONE Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 25010040515
Manufacturer: Aidapak Services, LLC
Category: Drug — Repacked Prescription Drug
Hazard: mis-labeling
Affected units: 500

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 (9)

PHYTONADIONE Tablet
5 mg has the following codes Pedigree: AD46312_22
EXP: 4/30/2014
Pedigree: W003061
EXP: 5/31/2014
Pedigree: W003737
Pedigree: AD25452_1
Pedigree: W003440
EXP: 5/31/2014.

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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Same hazard · mis labeling