Status
Ongoing
Drug Enforcement D-0025-2025
CGMP Deviations
Classification
Class II
Report Date
October 30, 2024
Termination Date
—
Product Information
- Product description
- 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.
- Product quantity
- 10845 bottles
- Reason for recall
- CGMP Deviations
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the US
Location & Firm
- Recalling firm
- Akron Pharma, Inc.
- Address
-
373 Us Highway 46 Ste 117, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0025-2025
- Event ID
- 95511
- Recall initiation date
- October 15, 2024
- Center classification date
- October 24, 2024
- Code info
- Lot #ODS230001A, ODS230002A, Exp. 10/2025; ODS230003A, Exp. 11/2025.
- More code info
- —