Drug product
OneLAX Docusate Sodium Liquid (docusate sodium 50 mg/5 mL) Stool Softener Laxative, 16 FL OZ (473 mL) bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., Fairfield, NJ 07004, NDC 71399-0039-06.
D-0025-2025
Product summary
- Event
- Event 95511
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 10845 bottles
- Official record key
drug-enforcement:D-0025-2025
Official wording
Reason: CGMP Deviations
Code information: Lot #ODS230001A, ODS230002A, Exp. 10/2025; ODS230003A, Exp. 11/2025.
Distribution pattern: Nationwide in the US
Derived failure modes
-
Manufacturing or process control
CGMP Deviations