Recalls / Class II

Class IID-489-2014

Product

FERROUS SULFATE, Tablet, 325 mg (65 mg Elem Fe), Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904759160

Affected lot / code info

FERROUS SULFATE, Tablet, 325 mg (65 mg Elem Fe) has the following codes Pedigree: W002717, EXP: 6/6/2014; Pedigree: W002826, EXP: 6/7/2014; Pedigree: AD60268_1, EXP: 5/22/2014.

Why it was recalled

Labeling: Label Mixup; FERROUS SULFATE, Tablet, 325 mg (65 mg Elem Fe) may be potentially mislabeled as COENZYME Q-10, Capsule, 100 mg, NDC 37205055065, Pedigree: W002711, EXP: 6/6/2014; VENLAFAXINE HCL, Tablet, 25 mg, NDC 00093019901, Pedigree: W002825, EXP: 12/31/2013; DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375710, Pedigree: AD60236_1, EXP: 5/22/2014.

Recalling firm

Firm

Aidapak Services, LLC

Notification channel

Telephone

Type

Voluntary: Firm initiated

Address

14301 Se 1st St, Vancouver, Washington 98684-3501

Distribution

Quantity

402 Tablets

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-489-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.