FDA Drug Recalls

Recalls / Class II

Class IID-875-2014

Product

ASPIRIN DR EC, Tablet, 81 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00182106105.

Affected lot / code info
ASPIRIN DR EC, Tablet, 81 mg has the following codes: Pedigree: AD52433_1, EXP: 5/17/2014; Pedigree: W003094, EXP: 6/13/2014.

Why it was recalled

Labeling: Label Mixup: ASPIRIN DR EC, Tablet, 81 mg may have potentially been mislabeled as one of the following drugs: SOTALOL HCL, Tablet, 120 mg, NDC 00093106001, Pedigree: AD49448_20, EXP: 5/17/2014; FOLIC ACID, Tablet, 1 mg, NDC 65162036110, Pedigree: W003097, EXP: 6/13/2014.

Recalling firm

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

Distribution

Quantity
1499 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-875-2014. 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