FDA Drug Recalls

Recalls / Class II

Class IID-585-2014

Product

ASPIRIN EC DR Tablet, 81 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 49348098015

Affected lot / code info
ASPIRIN EC DR, Tablet, 81 mg has the following codes Pedigree: AD28349_1, EXP: 2/28/2014; Pedigree: W003672, EXP: 2/28/2014.

Why it was recalled

Labeling: Label Mixup; ASPIRIN EC DR Tablet, 81 mg may be potentially mislabeled as MELATONIN, Tablet, 3 mg, NDC 51991001406, Pedigree: AD28322_7, EXP: 5/6/2014; DOCUSATE SODIUM, Capsule, 250 mg, NDC 00904789159, Pedigree: W003671, EXP: 6/25/2014.

Recalling firm

Firm
Aidapak Services, LLC
Notification channel
Telephone
Type
Voluntary: Firm initiated
Address
14301 Se 1st St, Vancouver, Washington 98684-3501

Distribution

Quantity
544 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-585-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class II recall: drug · FDA Drug Recalls