Recalls / Class II

Class IID-815-2014

Product

VALSARTAN, Tablet, 80 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00078035834.

Affected lot / code info

VALSARTAN, Tablet, 80 mg has the following codes: Pedigree: AD52372_4, EXP: 5/17/2014; Pedigree: AD65475_10, EXP: 5/28/2014; Pedigree: AD68025_1, EXP: 5/28/2014; Pedigree: AD70585_1, EXP: 5/29/2014; Pedigree: W002768, EXP: 6/10/2014; Pedigree: W003535, EXP: 6/21/2014; Pedigree: AD62995_4, EXP: 5/28/2014; Pedigree: AD73597_1, EXP: 5/31/2014; Pedigree: W002616, EXP: 6/4/2014.

Why it was recalled

Labeling: Label Mixup: VALSARTAN, Tablet, 80 mg may have potentially been mislabeled as one of the following drugs: TEMAZEPAM, Capsule, 7.5 mg, NDC 00378311001, Pedigree: AD49418_1, EXP: 5/17/2014; VALSARTAN, Tablet, 320 mg, NDC 00078036034, Pedigree: AD65475_7, EXP: 5/28/2014; ISOSORBIDE MONONITRATE, Tablet, 20 mg, NDC 62175010701, Pedigree: AD67989_10, EXP: 5/28/2014; CHOLECALCIFEROL, Tablet

Recalling firm

Firm

Aidapak Services, LLC

Notification channel

Telephone

Type

Voluntary: Firm initiated

Address

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

Distribution

Quantity

1440 Tablets

Distribution pattern

Repacked drugs were distributed in Arizona, California, Oregon, and Washington.

Timeline

Recall initiated

2013-07-02

FDA classified

2014-01-20

Posted by FDA

2014-01-29

Terminated

2014-02-07

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-815-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.