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Docusate Sodium 250 mg, 1 Softgel in blister card-foils, 100-count unit dose box, www.safecorheal...

FDA Recall #D-0060-2025 — Class II — November 11, 2024

Recall #D-0060-2025 Date: November 11, 2024 Classification: Class II Status: Ongoing

Product Description

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

Reason for Recall

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

Recalling Firm

Safecor Health, LLC — Woburn, MA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

587 boxes

Distribution

USA nationwide.

Code Information

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

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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