FDA recall D-588-2014

Aidapak Services, LLC · Class II · drug

Product

DOXYCYCLINE MONOHYDRATE Capsule, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 49884072703

Reason for recall

Labeling: Label Mixup; DOXYCYCLINE MONOHYDRATE Capsule, 100 mg may be potentially mislabeled as diphenhydrAMINE HCl, Tablet, 25 mg, NDC 00904555159, Pedigree: AD67992_4, EXP: 5/28/2014; DUTASTERIDE, Capsule, 0.5 mg, NDC 00173071215, Pedigree: AD52778_4, EXP: 5/20/2014.

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-588-2014