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Drug Enforcement D-936-2014

Labeling: Label Mixup: DOCUSATE SODIUM, Capsule, 250 mg may have potentially been mislabeled as one of the following drugs: SACCHAROMYCES BOULARDII LYO, Capsule, 250 mg, NDC 00414200007, Pedigree: W003030, EXP: 6/12/2014; ISOSORBIDE MONONITRATE ER, Tablet, 30 mg, NDC 62175012837, Pedigree: AD21790_64, EXP: 5/1/2014; TRIHEXYPHENIDYL HCL, Tablet, 1 mg (1/2 of 2 mg), NDC 00591533501, Pedigree: AD7

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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 00536375710.
Product quantity: 16,044 Capsules
Reason for recall: Labeling: Label Mixup: DOCUSATE SODIUM, Capsule, 250 mg may have potentially been mislabeled as one of the following drugs: SACCHAROMYCES BOULARDII LYO, Capsule, 250 mg, NDC 00414200007, Pedigree: W003030, EXP: 6/12/2014; ISOSORBIDE MONONITRATE ER, Tablet, 30 mg, NDC 62175012837, Pedigree: AD21790_64, EXP: 5/1/2014; TRIHEXYPHENIDYL HCL, Tablet, 1 mg (1/2 of 2 mg), NDC 00591533501, Pedigree: AD7
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-936-2014
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: W003054, EXP: 6/12/2014; Pedigree: AD21846_11, EXP: 5/1/2014; Pedigree: W002512, EXP: 6/3/2014; Pedigree: AD76675_1, EXP: 6/3/2014; Pedigree: W002694, EXP: 6/5/2014; Pedigree: AD46257_16, EXP: 5/15/2014; Pedigree: AD60236_1, EXP: 5/22/2014; Pedigree: AD60578_5, EXP: 5/29/2014; Pedigree: AD73521_13, EXP: 5/30/2014; Pedigree: W003242, EXP: 6/17/2014; Pedigree: W003315, EXP: 6/18/2014.
More code info: —