PlainRecalls
FDA Drug Moderate Class II Ongoing

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.

Reported: October 30, 2024 Initiated: October 15, 2024 #D-0025-2025

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.

Reason for Recall

CGMP Deviations

Details

Recalling Firm
Akron Pharma, Inc.
Units Affected
10845 bottles
Distribution
Nationwide in the US
Location
Fairfield, NJ

Frequently Asked Questions

What product was recalled?
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.. Recalled by Akron Pharma, Inc.. Units affected: 10845 bottles.
Why was this product recalled?
CGMP Deviations
Which agency issued this recall?
This recall was issued by the FDA Drug on October 30, 2024. Severity: Moderate. Recall number: D-0025-2025.