Drug product
Docusate Sodium 250 mg, 1 Softgel in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-101-01
D-0060-2025
Product summary
- Event
- Event 95659
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 587 boxes
- Official record key
drug-enforcement:D-0060-2025
Official wording
Reason: cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Code information: Lot# 34A0054, exp. date 05/07/2026
Distribution pattern: USA nationwide.
Derived failure modes
-
Manufacturing or process control
cGMP Deviations