FDAClass IIJanuary 29, 2014

Amantadine HCL recall: Labeling Error

AMANTADINE HCL, Capsule, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00781204801.

Why was Amantadine HCL recalled?

Labeling: Label Mixup: AMANTADINE HCL, Capsule, 100 mg may have potentially been mislabeled as one of the following drugs: ACARBOSE, Tablet, 25 mg, NDC 00054014025, Pedigree: W002725, EXP: 6/6/2014; clomiPRAMINE HCl, Capsule, 50 mg, NDC 51672401205, Pedigree: W002998, EXP: 6/11/2014; ASPIRIN EC DR, Tablet, 81 mg, NDC 49348098015, Pedigree: W003672, EXP: 2/28/2014; NIACIN TR, Capsule, 500 mg, N

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?

AMANTADINE HCL, Capsule, 100 mg has the following codes: Pedigree: W002726, EXP: 6/6/2014; Pedigree: W002997, EXP: 6/11/2014; Pedigree: W003674, EXP: 6/25/2014; Pedigree: W003323, EXP: 6/18/2014.

Product
AMANTADINE HCL, Capsule, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00781204801.
Recalling firm
Aidapak Services, LLC
Quantity
499 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