FDAClass IIJanuary 22, 2014

Nitrofurantoin Macrocrystals Capsule recall: Labeling Error

NITROFURANTOIN MACROCRYSTALS Capsule, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 47781030701

Why was Nitrofurantoin Macrocrystals Capsule recalled?

Labeling: Label Mixup; NITROFURANTOIN MACROCRYSTALS Capsule, 50 mg may be potentially mislabeled as PHYTONADIONE, Tablet, 5 mg, NDC 25010040515, Pedigree: AD25452_1, EXP: 4/30/2014.

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?

NITROFURANTOIN MACROCRYSTALS, Capsule, 50 mg has the following code Pedigree: AD25452_4, EXP: 5/3/2014.

Product
NITROFURANTOIN MACROCRYSTALS Capsule, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 47781030701
Recalling firm
Aidapak Services, LLC
Quantity
102 Capsules
Distribution
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Recall date
January 22, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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