FDA Drug Recalls

Recalls / Class II

Class IID-579-2014

Product

LACTOBACILLUS GG Capsule, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 49100036374

Affected lot / code info
LACTOBACILLUS GG, Capsule has the following codes Pedigree: AD39588_4, EXP: 5/13/2014 Pedigree: AD65457_16, EXP: 5/24/2014 Pedigree: AD70655_8, EXP: 5/29/2014 Pedigree: AD73627_17, EXP: 5/30/2014 Pedigree: W003051, EXP: 6/12/2014 Pedigree: W003216, EXP: 6/14/2014 Pedigree: AD42584_12, EXP: 5/14/2014 Pedigree: AD46300_11, EXP: 5/15/2014 Pedigree: W002968, EXP: 6/11/2014 Pedigree: AD68019_1, EXP: 5/28/2014 Pedigree: W003172, EXP: 6/13/2014 Pedigree: W003173, EXP: 6/13/2014

Why it was recalled

Labeling: Label Mixup; LACTOBACILLUS GG Capsule may be potentially mislabeled as VITAMIN B COMPLEX W/C, Capsule, NDC 54629008001, Pedigree: AD39560_4, EXP: 5/13/2014; DOCUSATE SODIUM, Capsule, 50 mg, NDC 67618010060, Pedigree: AD65457_13, EXP: 5/24/2014; VITAMIN B COMPLEX WITH C/FOLIC ACID, Tablet, NDC 60258016001, Pedigree: AD70655_17, EXP: 5/28/2014; TACROLIMUS, Capsule, 1 mg, NDC 00781210

Recalling firm

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

Distribution

Quantity
1,970 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-579-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.