FDA Drug Recalls

Recalls / Class II

Class IID-721-2014

Product

DOCUSATE SODIUM, Capsule, 50 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 67618010060

Affected lot / code info
DOCUSATE SODIUM, Capsule, 50 mg has the following codes Pedigree: AD60211_8, EXP: 5/21/2014; Pedigree: AD62865_10, EXP: 5/23/2014; Pedigree: AD65457_13, EXP: 5/24/2014.

Why it was recalled

Labeling:Label Mixup; DOCUSATE SODIUM, Capsule, 50 mg may be potentially mislabeled as LEVOTHYROXINE SODIUM, Tablet, 112 mcg, NDC 00378181101, Pedigree: AD60211_1, EXP: 5/21/2014; MEXILETINE HCL, Capsule, 150 mg, NDC 00093873901, Pedigree: AD62865_7, EXP: 5/23/2014; CHOLECALCIFEROL, Tablet, 5000 units, NDC 00761017840, Pedigree: AD65457_10, EXP: 5/24/2014.

Recalling firm

Firm
Aidapak Services, LLC
Notification channel
Telephone
Type
Voluntary: Firm initiated
Address
14301 Se 1st St, Vancouver, Washington 98684-3501

Distribution

Quantity
181 Capsules
Distribution pattern
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.

Timeline

Recall initiated
2013-07-02
FDA classified
2014-01-16
Posted by FDA
2014-01-22
Terminated
2014-02-07
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-721-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.