RecallRadar

FDA Drug recall D-768-2014

ATOMOXETINE HCL, Capsule, 80 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00002325030

On 2014-01-29 the FDA classified a Class II recall of ATOMOXETINE HCL, Capsule, 80 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00002325030 by Aidapak Services, citing labeling: Label Mixup: ATOMOXETINE HCL, Capsule, 80 mg may be potentially mis-labeled as one of the following drugs: ATOMOXETINE HCL, Capsule, 18 mg, NDC 00002323830, Pedigree: AD….

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-768-2014
ClassificationClass II
Statusterminated
Initiated2013-07-02
Published2014-01-29
Last updated2026-09-13 11:51 UTC
CompanyAidapak Services
DistributionAZ, CA, OR, WA

Product

ATOMOXETINE HCL, Capsule, 80 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00002325030.

Reason

Labeling: Label Mixup: ATOMOXETINE HCL, Capsule, 80 mg may be potentially mis-labeled as one of the following drugs: ATOMOXETINE HCL, Capsule, 18 mg, NDC 00002323830, Pedigree: AD30140_16, EXP: 5/7/2014; PRENATAL MULTIVITAMIN/MULTIMINERAL, Tablet, 0 mg, NDC 00904531360, Pedigree: W003706, EXP: 6/25/2014; RANOLAZINE ER, Tablet, 500 mg, NDC 61958100301, Pedigree: AD60272_40, EXP: 5/22/2014; PRO

Identifiers

code_info
ATOMOXETINE HCL, Capsule, 80 mg has the following codes: Pedigree: AD30140_19, EXP: 5/7/2014; Pedigree: W003685, EXP…ATOMOXETINE HCL, Capsule, 80 mg has the following codes: Pedigree: AD30140_19, EXP: 5/7/2014; Pedigree: W003685, EXP: 6/25/2014; Pedigree: AD60272_49, EXP: 5/22/2014; Pedigree: W003003, EXP: 6/11/2014.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-768-2014%22

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