October 2024 FDA Recall Drug by Akron Pharma, Inc.
D-0025-2025 - CGMP Deviations

This Class II drug recall was voluntarily initiated by Akron Pharma, Inc. on October 15, 2024 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0025-2025

Reason for Recall
CGMP Deviations
Initiated
10-15-2024
Reported
10-30-2024
Quantity
10845 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
95511
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Akron Pharma, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the US
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# ODS230001A, ODS230002A, Exp. 10/2025; ODS230003A, Exp. 11/2025.