FDAClass IIJanuary 22, 2014

Docusate Sodium recall: Labeling Error

DOCUSATE SODIUM, Capsule, 250 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904789159

Why was Docusate Sodium recalled?

Labeling: Label Mixup; DOCUSATE SODIUM, Capsule, 250 mg may be potentially mislabeled as ATROPINE SULFATE/DIPHENOXYLATE HCL, Tablet, 0.025 mg/2.5 mg, NDC 00378041501, Pedigree: AD65475_13, EXP: 5/28/2014; VALSARTAN, Tablet, 80 mg, NDC 00078035834, Pedigree: AD68025_1, EXP: 5/28/2014; PANTOPRAZOLE SODIUM DR, Tablet, 40 mg, NDC 64679043402, Pedigree: AD37063_10, EXP: 5/13/2014; DOCUSATE SODIUM

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, 250 mg has the following codes Pedigree: AD68028_1, EXP: 5/28/2014; Pedigree: AD68022_1, EXP: 5/28/2014; Pedigree: AD37072_1, EXP: 5/13/2014; Pedigree: AD37072_4, EXP: 5/13/2014; Pedigree: AD56924_1, EXP: 5/21/2014; Pedigree: W003671, EXP: 6/25/2014; Pedigree: W002920, EXP: 6/10/2014.

Product
DOCUSATE SODIUM, Capsule, 250 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904789159
Recalling firm
Aidapak Services, LLC
Quantity
4,318 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