FDA recall D-612-2014

Aidapak Services, LLC · Class II · drug

Product

TRIMETHOBENZAMIDE HCl Capsule, 300 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 53489037601

Reason for recall

Labeling: Label Mixup; TRIMETHOBENZAMIDE HCl, Capsule, 300 mg may be potentially mislabeled as GABAPENTIN, Tablet, 600 mg, NDC 00228263611, Pedigree: AD21965_7, EXP: 5/1/2014; CHOLECALCIFEROL, Capsule, 5000 units, NDC 00904598660, Pedigree: AD70629_19, EXP: 5/29/2014; SODIUM BICARBONATE, Tablet, 650 mg, NDC 64980018210, Pedigree: W002970, EXP: 6/11/2014.

Distribution

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

Key facts

Status: Terminated
Initiation date: 2013-07-02
Report date: 2014-01-22
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-612-2014