FDAClass IIJanuary 22, 2014

Docusate Sodium Capsule recall: Labeling Error

DOCUSATE SODIUM Capsule, 100 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 57896040110

Why was Docusate Sodium Capsule recalled?

Labeling:Label Mixup; DOCUSATE SODIUM Capsule, 100 mg may be potentially mislabeled as DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375701, Pedigree: AD37063_4, EXP: 5/13/2014; tiZANidine HCl, Tablet, 2 mg, NDC 00378072219, Pedigree: W002975, EXP: 6/11/2014.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

DOCUSATE SODIUM, Capsule, 100 mg has the following codes Pedigree: AD37063_1, EXP: 5/13/2014; Pedigree: W002977, EXP: 6/11/2014.

Product
DOCUSATE SODIUM Capsule, 100 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 57896040110
Recalling firm
Aidapak Services, LLC
Quantity
1,998 Capsules
Distribution
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Recall date
January 22, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls