Recalls / Class II

Class IID-520-2014

Product

LOSARTAN POTASSIUM Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 16714058102

Affected lot / code info

LOSARTAN POTASSIUM Tablet, 25 mg has the following codes Pedigree: AD67989_7, EXP: 5/28/2014; Pedigree: W003845, EXP: 6/27/2014; Pedigree: W003899, EXP: 6/27/2014; Pedigree: AD22616_7, EXP: 5/2/2014.

Why it was recalled

Labeling: Label Mixup; LOSARTAN POTASSIUM, Tablet, 25 mg may be potentially mislabeled as DOCUSATE SODIUM, Capsule, 250 mg, NDC 00904789159, Pedigree: AD68028_1, EXP: 5/28/2014; METOPROLOL TARTRATE, Tablet, 50 mg, NDC 00093073301, Pedigree: W003844, EXP: 6/27/2014; LACTOBACILLUS ACIDOPHILUS, Tablet, 35 Million, NDC 00536718101, Pedigree: W003865, EXP: 6/27/2014; OXYBUTYNIN CHLORIDE, 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

448 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-520-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.