FDA recall D-876-2014

Aidapak Services, LLC · Class II · drug

Product

SENNOSIDES, Tablet, 8.6 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00182109301.

Reason for recall

Labeling: Label Mixup: SENNOSIDES, Tablet, 8.6 mg may have potentially been mislabeled as one of the following drugs: FEXOFENADINE HCL, Tablet, 180 mg, NDC 41167412003, Pedigree: AD62834_1, EXP: 5/23/2014; TRIMETHOBENZAMIDE HCL, Capsule, 300 mg, NDC 53489037601, Pedigree: W002976, EXP: 6/11/2014; LORATADINE, Tablet, 10 mg, NDC 45802065078, Pedigree: W003253, EXP: 6/17/2014.

Distribution

Repacked drugs were distributed in Arizona, California, Oregon, and Washington.

Key facts

Status: Terminated
Initiation date: 2013-07-02
Report date: 2014-01-29
Termination date: 2014-02-07
Voluntary/Mandated: Voluntary: Firm initiated
Location: Vancouver, WA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-876-2014