D-0060-2025 Class II Ongoing
FDA drug recall D-0060-2025 was initiated by Safecor Health, LLC on November 11, 2024 and is designated Class II. Reason for recall: cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity. The recall status is ongoing. Affected quantity: 587 boxes.
Recall Details
- Product Type
- Drugs
- Report Date
- November 27, 2024
- Initiation Date
- November 11, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 587 boxes
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.
Distribution Pattern
USA nationwide.
Code Information
Lot# 34A0054, exp. date 05/07/2026