FDA recall D-1437-2019

Geritrex, LLC · Class II · drug

Product

Senna (sennosides 8.8 mg) Syrup 8 fl oz. (236 mL) bottles, Distributed by Geritrex, LLC 40 Commercial Avenue Middletown, NY 10941, NDC 54162-007-08

Reason for recall

Failed Impurities/Degradation Specifications: Atypical odor and unpleasant taste was reported

Distribution

Nationwide within the United States

Key facts

Status
Terminated
Initiation date
2019-05-06
Report date
2019-06-19
Termination date
2024-02-21
Voluntary/Mandated
Voluntary: Firm initiated
Location
Middletown, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1437-2019