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U.S. Department of Health and Human Services

Enforcement Report - Week of January 22, 2014

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Product Detail

Product Description LACTOBACILLUS GG Capsule, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 49100036374
Recall Number D-579-2014
Classification Class II
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
Product Distributed Qty 1,970 Capsules
Reason For Recall 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 00781210301, Pedigree: AD73627_14, EXP: 5/30/2014; LEVOTHYROXINE SODIUM, Tablet, 88 mcg, NDC 00378180701, Pedigree: W003047, EXP: 6/12/2014; MYCOPHENOLATE MOFETIL, Capsule, 250 mg, NDC 00781206701, Pedigree: W003215, EXP: 6/14/2014; ASCORBIC ACID, Tablet, 250 mg, NDC 00904052260, Pedigree: AD42970_1, EXP: 5/14/2014; PHOSPHORUS, Tablet, 250 mg, NDC 64980010401, Pedigree: AD46300_8, EXP: 5/15/2014; LEVOTHYROXINE SODIUM, Tablet, 88 mcg, NDC 00378180701, Pedigree: W002967, EXP: 6/11/2014; VARENICLINE, Tablet, 0.5 mg, NDC 00069046856, Pedigree: AD62829_1, EXP: 5/22/2014; PANCRELIPASE DR, Capsule, NDC 42865010302, Pedigree: W003171, EXP: 6/13/2014; LACTOBACILLUS GG, Capsule, NDC 49100036374, Pedigree: W003172, EXP: 6/13/2014.

Event Detail

Event Id 65707
Product Type Drugs
Status Ongoing
Recalling Firm Aidapak Services, LLC
City Vancouver
State WA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-07-02
Initial Firm Notification of Consignee or Public Telephone
Distribution Pattern Repacked drugs were distributed in Arizona, California, Oregon, and Washington.