FDA Drug Recalls

Recalls / Class II

Class IID-656-2014

Product

SENNOSIDES Tablet, 8.6 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 60258095001

Affected lot / code info
SENNOSIDES, Tablet, 8.6 mg has the following code Pedigree: AD37063_17, EXP: 5/13/2014.

Why it was recalled

Labeling:Label Mixup; SENNOSIDES Tablet, 8.6 mg may be potentially mislabeled as SACCHAROMYCES BOULARDII LYO, Capsule, 250 mg, NDC 00414200007, Pedigree: AD37063_7, EXP: 5/13/2014.

Recalling firm

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

Distribution

Quantity
300 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-656-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.