FDA recall D-634-2014

Aidapak Services, LLC · Class II · drug

Product

DOCUSATE SODIUM Capsule, 100 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 57896040110

Reason for recall

Labeling:Label Mixup; DOCUSATE SODIUM Capsule, 100 mg may be potentially mislabeled as DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375701, Pedigree: AD37063_4, EXP: 5/13/2014; tiZANidine HCl, Tablet, 2 mg, NDC 00378072219, Pedigree: W002975, 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-634-2014