Recalls / Class II

Class IID-683-2014

Product

guaiFENesin ER Tablet, 600 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 63824000834

Affected lot / code info

guaiFENesin ER, Tablet, 600 mg has the following codes Pedigree: AD62834_4, EXP: 5/24/2014; Pedigree: AD62834_7, EXP: 5/24/2014; Pedigree: W003514, EXP: 6/21/2014; Pedigree: W003574, EXP: 6/24/2014; Pedigree: W003850, EXP: 6/27/2014; Pedigree: W003931, EXP: 6/28/2014; Pedigree: AD46429_1, EXP: 5/15/2014; Pedigree: AD73592_1, EXP: 5/31/2014.

Why it was recalled

Labeling:Label Mixup; guaiFENesin ER, Tablet, 600 mg may be potentially mislabeled as PRENATAL MULTIVITAMIN/ MULTIMINERAL, Tablet, NDC 51991056601, Pedigree: AD62829_18, EXP: 5/24/2014; guaiFENesin ER, Tablet, 600 mg, NDC 63824000834, Pedigree: AD62834_4, EXP: 5/24/2014; diphenhydrAMINE HCl, Tablet, 25 mg, NDC 00904555159, Pedigree: W003513, EXP: 6/21/2014; DOCUSATE SODIUM, Capsule, 250 mg,

Recalling firm

Firm

Aidapak Services, LLC

Notification channel

Telephone

Type

Voluntary: Firm initiated

Address

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

Distribution

Quantity

480 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-683-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.