FDAClass IIJanuary 22, 2014

Niacin TR recall: Labeling Error

NIACIN TR, Tablet, 250 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 10939043533

Why was Niacin TR recalled?

Labeling: Label Mixup; NIACIN TR, Tablet, 250 mg may be potentially mislabeled as SOLIFENACIN SUCCINATE, Tablet, 5 mg, NDC 51248015001, Pedigree: W003755, EXP: 6/26/2014.

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?

NIACIN TR, Tablet, 250 mg has the following code Pedigree: W003756, EXP: 5/31/2014.

Product
NIACIN TR, Tablet, 250 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 10939043533
Recalling firm
Aidapak Services, LLC
Quantity
101 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