FDA Drug Recalls

Recalls / Class II

Class IID-946-2014

Product

LACTOBACILLUS ACIDOPHILUS, Tablet, 35 MILLION, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536718101.

Affected lot / code info
LACTOBACILLUS ACIDOPHILUS, Tablet, 35 MILLION has the following codes: Pedigree: W003865, EXP: 6/27/2014.

Why it was recalled

Labeling: Label Mixup: LACTOBACILLUS ACIDOPHILUS, Tablet, 35 MILLION may have potentially been mislabeled as the following drug: REPAGLINIDE, Tablet, 1 mg, NDC 00169008281, Pedigree: W003924, EXP: 6/28/2014.

Recalling firm

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

Distribution

Quantity
100 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-946-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.