FDA Drug Recalls

Recalls / Class II

Class IID-601-2014

Product

ETODOLAC Tablet, 400 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 51672401801

Affected lot / code info
ETODOLAC, Tablet, 400 mg has the following code Pedigree: W003734, EXP: 6/26/2014.

Why it was recalled

Labeling: Label Mixup; ETODOLAC, Tablet, 400 mg may be potentially mislabeled as PANCRELIPASE DR, Capsule, 12000 /38000 /60000 USP units, NDC 00032121201, Pedigree: W003731, EXP: 6/26/2014.

Recalling firm

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

Distribution

Quantity
101 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-601-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.