Recalls / Class II

Class IID-483-2014

Product

diphenhydrAMINE HCl, Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00904555159

Affected lot / code info

diphenhydrAMINE HCl, Tablet, 25 mg has the following codes Pedigree: AD33897_13, EXP: 5/9/2014; Pedigree: W002775, EXP: 6/6/2014; Pedigree: W003513, EXP: 6/21/2014; Pedigree: AD67992_4, EXP: 5/28/2014.

Why it was recalled

Labeling: Label Mixup; diphenhydrAMINE HCl, Tablet, 25 mg may be potentially mislabeled as ATORVASTATIN CALCIUM, Tablet, 40 mg, NDC 00378212177, Pedigree: AD33897_10, EXP: 5/9/2014; ATORVASTATIN CALCIUM, Tablet, 10 mg, NDC 00378201577, Pedigree: W002774, EXP: 6/6/2014; PRENATAL MULTIVITAMIN/ MULTIMINERAL, Tablet, NDC 51991056601, Pedigree: W003511, EXP: 6/21/2014; VENLAFAXINE, Tablet, 25 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

901 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-483-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.