OneLAX Docusate Sodium Liquid (docusate sodium 50 mg/5 mL) Stool Softener Laxative, 16 FL OZ (473 mL) bottle, Akron Phar
Summary
The FDA issued a Class II for OneLAX Docusate Sodium Liquid (docusate sodium 50 mg/5 mL) Stool Softener Laxati by Akron Pharma, Inc.. Reason: CGMP Deviations.
Details
Source
Drug Recall
External ID
D-0025-2025
Action Date
2024-10-30
Status
Ongoing
Category
drug
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.
Lot/Code Info: Lot #ODS230001A, ODS230002A, Exp. 10/2025; ODS230003A, Exp. 11/2025.
Quantity Affected: 10845 bottles
Reason for Recall
CGMP Deviations
Distribution
Nationwide in the US
Type: Voluntary: Firm initiated
Recall Initiated: 2024-10-15
Company
Fairfield, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 37 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Akron Pharma, Inc. has 11 FDA actions in our database, including 11 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Akron Pharma, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Akron Pharma, Inc. have FDA actions?
Akron Pharma, Inc. has 11 FDA actions in our database, including 11 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0025-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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