FDA recall D-0025-2025

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.

Reason for recall

CGMP Deviations

Distribution

Nationwide in the US

Key facts

Status

Ongoing

Initiation date

2024-10-15

Report date

2024-10-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Fairfield, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0025-2025