FDAClass IIJanuary 22, 2014

Phytonadione Tablet recall: Labeling Error

PHYTONADIONE Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 25010040515

Why was Phytonadione Tablet recalled?

Labeling: Label Mixup; PHYTONADIONE Tablet, 5 mg may be potentially mislabeled as medroxyPROGESTERone ACETATE, Tablet, 10 mg, NDC 59762374202, Pedigree: AD46312_19, EXP: 5/16/2014; HYDROCORTISONE, Tablet, 5 mg, NDC 00603389919, Pedigree: W003060, EXP: 6/12/2014; GALANTAMINE HBR ER, Capsule, 24 mg, NDC 47335083783, Pedigree: W003735, EXP: 5/31/2014; TORSEMIDE, Tablet, 10 mg, NDC 31722053001,

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
PHYTONADIONE Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 25010040515
Recalling firm
Aidapak Services, LLC
Quantity
500 Tablets
Distribution
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Recall date
January 22, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls