FDA Drug Recalls

Recalls / Class II

Class IID-618-2014

Product

LACTOBACILLUS ACIDOPHILUS Capsule, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 54629011101

Affected lot / code info
LACTOBACILLUS ACIDOPHILUS, Capsule has the following codes Pedigree: AD65311_7, EXP: 5/24/2014; Pedigree: AD65311_4, EXP: 5/24/2014.

Why it was recalled

Labeling:Label Mixup; LACTOBACILLUS ACIDOPHILUS Capsule may be potentially mislabeled as CHOLECALCIFEROL, Tablet, 2000 units, NDC 00904615760, Pedigree: AD65311_1, EXP: 5/24/2014; PANCRELIPASE DR, Capsule, 24000 /76000 /120000 USP units, NDC 00032122401, Pedigree: AD65457_4, EXP: 5/24/2014.

Recalling firm

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

Distribution

Quantity
2,392 Capsules
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-618-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.