Drug Enforcement D-0060-2025

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

Status

Ongoing

Classification

Class II

Report Date

November 27, 2024

Termination Date

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Product Information

Product description
Docusate Sodium 250 mg, 1 Softgel in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-101-01
Product quantity
587 boxes
Reason for recall
cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
USA nationwide.

Location & Firm

Recalling firm
Safecor Health, LLC
Address
317 New Boston St, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0060-2025
Event ID
95659
Recall initiation date
November 11, 2024
Center classification date
November 19, 2024
Code info
Lot# 34A0054, exp. date 05/07/2026
More code info
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