FDA recall D-1522-2019

Geritrex, LLC · Class II · drug

Product

Gericare Diocto Liquid Docusate Sodium Stool Softener, 50 mg/5mL, 16 FL OZ (473 ml), Dist. BY: Gericare Pharmaceuticals corp. 1650 63rd Street Brooklyn, NY 11204, NDC 57896-403-16

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-1522-2019