Drug Enforcement D-935-2014

Labeling: Label Mixup: DOCUSATE SODIUM, Capsule, 250 mg may have potentially been mislabeled as one of the following drugs: PIOGLITAZONE, Tablet, 15 mg, NDC 00591320530, Pedigree: AD25452_10, EXP: 4/30/2014; PHOSPHORUS, Tablet, 250 mg, NDC 64980010401, Pedigree: AD54498_1, EXP: 5/20/2014; LACTOBACILLUS GG, Capsule, 0, NDC 49100036374, Pedigree: AD65457_16, EXP: 5/24/2014; guaiFENesin ER, Table

1 Views

Status

Terminated

Classification

Class II

Report Date

January 29, 2014

Termination Date

February 7, 2014

Product Information

Product description
DOCUSATE SODIUM, Capsule, 250 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536375701.
Product quantity
1204 Capsules
Reason for recall
Labeling: Label Mixup: DOCUSATE SODIUM, Capsule, 250 mg may have potentially been mislabeled as one of the following drugs: PIOGLITAZONE, Tablet, 15 mg, NDC 00591320530, Pedigree: AD25452_10, EXP: 4/30/2014; PHOSPHORUS, Tablet, 250 mg, NDC 64980010401, Pedigree: AD54498_1, EXP: 5/20/2014; LACTOBACILLUS GG, Capsule, 0, NDC 49100036374, Pedigree: AD65457_16, EXP: 5/24/2014; guaiFENesin ER, Table
Recall initiation reason
—
Initial firm notification
Telephone
Distribution pattern
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.

Location & Firm

Recalling firm
Aidapak Services, LLC
Address
14301 Se 1st St

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-935-2014
Event ID
65690
Recall initiation date
July 2, 2013
Center classification date
January 20, 2014
Code info
DOCUSATE SODIUM, Capsule, 250 mg has the following codes: Pedigree: AD25452_13, EXP: 5/3/2014; Pedigree: AD54498_4, EXP: 5/20/2014; Pedigree: AD65457_19, EXP: 5/24/2014; Pedigree: W003358, EXP: 6/19/2014; Pedigree: W003558, EXP: 6/24/2014; Pedigree: AD60211_11, EXP: 5/22/2014; Pedigree: W003114, EXP: 6/13/2014; Pedigree: AD37063_4, EXP: 5/13/2014; Pedigree: AD73652_1, EXP: 5/29/2014.
More code info
—