FDAClass IINovember 27, 2024

Docusate Sodium 250 mg recall: CGMP Deviations

Docusate Sodium 250 mg, 1 Softgel in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-101-01

Why was Docusate Sodium 250 mg recalled?

cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA 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?

Lot# 34A0054, exp. date 05/07/2026

Product
Docusate Sodium 250 mg, 1 Softgel in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-101-01
Recalling firm
Safecor Health, LLC
Quantity
587 boxes
Distribution
USA nationwide.
Recall date
November 27, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
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