FDA recall D-1527-2019

Geritrex, LLC · Class II · drug

Product

Preferred Plus Dioctyl Liquid Stool Softener (Docusate Sodium), 50mg/5mL, 16 FL. Oz. (1 PT.) 473 mL, Manufactured by RIJ Pharmaceutical Corp. 40 Commercial Avenue Middletown, NY 10941, Distributed by Kinray Inc. Whitestone, NY 11357, NDC 53807-216-16

Reason for recall

cGMP Deviations: Products may have microbial contamination.

Distribution

U.S.A. Nationwide

Key facts

Status: Terminated
Initiation date: 2019-05-31
Report date: 2019-07-31
Termination date: 2024-02-02
Voluntary/Mandated: Voluntary: Firm initiated
Location: Middletown, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1527-2019