FDA recall D-0848-2018

RIJ Pharmaceutical LLC · Class II · drug

Product

GeriCare Senna Syrup (Sennosides 8.8 mg), 8 fl oz (237 mL) bottles, Dist, by Gericare Pharmaceuticals 1650 63rd Street Brooklyn, NY 11204, NDC 57696-452-08, UPC 357896452087

Reason for recall

CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.

Distribution

Nationwide in the USA

Key facts

Status: Terminated
Initiation date: 2018-05-07
Report date: 2018-06-20
Termination date: 2023-04-07
Voluntary/Mandated: Voluntary: Firm initiated
Location: Middletown, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0848-2018