Recalls / Class II

Class IID-560-2014

Product

LACTOBACILLUS ACIDOPHILUS Capsule, 500 Million CFU, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 43292050022

Affected lot / code info

LACTOBACILLUS ACIDOPHILUS Capsule, 500 Million CFU has the following codes Pedigree: AD46257_28, EXP: 5/15/2014; Pedigree: AD30028_10, EXP: 5/7/2014; Pedigree: AD60240_20, EXP: 5/22/2014.

Why it was recalled

Labeling: Label Mixup; LACTOBACILLUS ACIDOPHILUS, Capsule, 500 Million CFU may be potentially mislabeled as MELATONIN, Tablet, 3 mg, NDC 08770140813, Pedigree: AD46257_56, EXP: 5/15/2014; MELATONIN, Tablet, 3 mg, NDC 08770140813, Pedigree: AD30028_28, EXP: 5/7/2014; CRANBERRY EXTRACT/VITAMIN C, Capsule, 450 mg/125 mg, NDC 31604014271, Pedigree: AD60240_11, EXP: 5/22/2014.

Recalling firm

Firm

Aidapak Services, LLC

Notification channel

Telephone

Type

Voluntary: Firm initiated

Address

14301 Se 1st St, Vancouver, Washington 98684-3501

Distribution

Quantity

700 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-560-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.