PlainRecalls
FDA Drug Moderate Class II Ongoing

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

Reported: November 27, 2024 Initiated: November 11, 2024 #D-0060-2025

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.

Details

Recalling Firm
Safecor Health, LLC
Units Affected
587 boxes
Distribution
USA nationwide.
Location
Woburn, MA

Frequently Asked Questions

What product was recalled?
Docusate Sodium 250 mg, 1 Softgel in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-101-01. Recalled by Safecor Health, LLC. Units affected: 587 boxes.
Why was this product recalled?
cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Which agency issued this recall?
This recall was issued by the FDA Drug on November 27, 2024. Severity: Moderate. Recall number: D-0060-2025.