FDAClass IIJanuary 29, 2014

Niacin TR recall: Labeling Error

NIACIN TR, Capsule, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00904063160.

Why was Niacin TR recalled?

Labeling: Label Mixup: NIACIN TR, Capsule, 500 mg may have potentially been mislabeled as one of the following drugs: PERPHENAZINE, Tablet, 16 mg, NDC 00603506321, Pedigree: AD46265_49, EXP: 5/15/2014; MELATONIN, Tablet, 1 mg, NDC 47469000466, Pedigree: AD60240_14, EXP: 5/22/2014; CRANBERRY EXTRACT/VITAMIN C, Capsule, 450 mg/125 mg, NDC 31604014271, Pedigree: W002693, EXP: 6/5/2014; GLUCOSAMIN

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, Capsule, 500 mg has the following codes: Pedigree: AD46257_22, EXP: 5/15/2014; Pedigree: AD60240_17, EXP: 5/22/2014; Pedigree: W002696, EXP: 6/5/2014; Pedigree: AD73521_22, EXP: 5/30/2014; Pedigree: W003318, EXP: 6/18/2014.

Product
NIACIN TR, Capsule, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00904063160.
Recalling firm
Aidapak Services, LLC
Quantity
504 Capsules
Distribution
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Recall date
January 29, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls