FDA recall D-465-2014

Aidapak Services, LLC · Class II · drug

Product

OMEGA-3 FATTY ACID, Capsule, 1000 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904404360

Reason for recall

Labeling: Label Mixup; OMEGA-3 FATTY ACID, Capsule, 1000 mg may be potentially mis-labeled as DOCUSATE CALCIUM, Capsule, 240 mg, NDC 00536375501, Pedigree: AD33897_16, EXP: 5/9/2014; OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 00904404360, Pedigree: AD33897_19, EXP: 5/9/2014; PSEUDOEPHEDRINE HCL, Tablet, 60 mg, NDC 00904512559, Pedigree: W002856, EXP: 6/7/2014; DOCUSATE SODIUM, Capsule, 50 mg, N

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-465-2014