FDA Drug Recalls

Recalls / Class II

Class IID-912-2014

Product

MESALAMINE DR, Capsule, 400 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00430075327.

Affected lot / code info
MESALAMINE DR, Capsule, 400 mg has the following codes: Pedigree: AD34934_1, EXP: 1/31/2014.

Why it was recalled

Labeling: Label Mixup: MESALAMINE DR, Capsule, 400 mg may have potentially been mislabeled as the following drug: CHLOROPHYLLIN COPPER COMPLEX, Tablet, 100 mg, NDC 11868000901, Pedigree: AD34928_1, EXP: 5/9/2014.

Recalling firm

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

Distribution

Quantity
180 Capsules
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-912-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.