Recalling firm
Akron Pharma, Inc.
Product type
Drug
Status
Ongoing
Report date
2024-10-30
Distribution
Nationwide in the US
Firm state
NJ
Product quantity
10845 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPAReason for recall
CGMP Deviations
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.
Code / lot info
Lot #ODS230001A, ODS230002A, Exp. 10/2025; ODS230003A, Exp. 11/2025.
Other recalls SPEQ maps to Risk Management & CAPA
See all Risk Management & CAPA recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.