Drug Enforcement D-934-2014

Labeling: Label Mixup: DOCUSATE CALCIUM, Capsule, 240 mg may have potentially been mislabeled as one of the following drugs: diphenhydrAMINE HCl, Tablet, 25 mg, NDC 00904555159, Pedigree: AD33897_13, EXP: 5/9/2014; DUTASTERIDE, Capsule, 0.5 mg, NDC 00173071215, Pedigree: AD49610_1, EXP: 5/16/2014; diphenhydrAMINE HCl, Tablet, 25 mg, NDC 00904555159, Pedigree: W002775, EXP: 6/6/2014; VITAMIN B

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Status

Terminated

Classification

Class II

Report Date

January 29, 2014

Termination Date

February 7, 2014

Product Information

Product description
DOCUSATE CALCIUM, Capsule, 240 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536375501.
Product quantity
1109 Capsules
Reason for recall
Labeling: Label Mixup: DOCUSATE CALCIUM, Capsule, 240 mg may have potentially been mislabeled as one of the following drugs: diphenhydrAMINE HCl, Tablet, 25 mg, NDC 00904555159, Pedigree: AD33897_13, EXP: 5/9/2014; DUTASTERIDE, Capsule, 0.5 mg, NDC 00173071215, Pedigree: AD49610_1, EXP: 5/16/2014; diphenhydrAMINE HCl, Tablet, 25 mg, NDC 00904555159, Pedigree: W002775, EXP: 6/6/2014; VITAMIN B
Recall initiation reason
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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
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Codes & Dates

Recall number
D-934-2014
Event ID
65690
Recall initiation date
July 2, 2013
Center classification date
January 20, 2014
Code info
DOCUSATE CALCIUM, Capsule, 240 mg has the following codes: Pedigree: AD33897_16, EXP: 5/9/2014; Pedigree: AD49582_16, EXP: 5/16/2014; Pedigree: W002776, EXP: 6/6/2014; Pedigree: W003821, EXP: 6/27/2014.
More code info
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