FDAClass IIJanuary 29, 2014

Atomoxetine HCL recall: Labeling Error

ATOMOXETINE HCL, Capsule, 40 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00002322930.

Why was Atomoxetine HCL recalled?

Labeling: Label Mixup: ATOMOXETINE HCL, Capsule, 40 mg may be potentially mis-labeled as OLANZAPINE, Tablet, 7.5 mg, NDC 60505311203, Pedigree: AD21790_76, EXP: 5/1/2014; ARIPiprazole, Tablet, 2 mg, NDC 59148000613, Pedigree: AD46265_19, EXP: 5/15/2014; OLANZapine, Tablet, 7.5 mg, NDC 55111016530, Pedigree: AD60272_79, EXP: 5/22/2014; OLANZapine, Tablet, 7.5 mg, NDC 55111016530, Pedigree: AD73

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?

ATOMOXETINE HCL, Capsule, 40 mg has the following codes: Pedigree: AD21790_82, EXP: 5/1/2014; Pedigree: AD46265_52, EXP: 5/15/2014; Pedigree: AD60272_89, EXP: 5/22/2014; Pedigree: AD73525_67, EXP: 5/30/2014; Pedigree: W003014, EXP: 6/11/2014.

Product
ATOMOXETINE HCL, Capsule, 40 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00002322930.
Recalling firm
Aidapak Services, LLC
Quantity
180 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