FDA recall D-0377-2022

Lohxa, LLC · Class I · drug

Product

SENNA Syrup (sennosides) 8.8 mg/ 5 mL unit-dose cups, packaged in 24 cups per carton, Mfg for: AvKARE, TN 38478, NDC 50262-731-24.

Reason for recall

Microbial Contamination of Non-Sterile Product

Distribution

Product was distributed to one wholesale who further distributed the product nationwide in the USA

Key facts

Status
Terminated
Initiation date
2021-12-21
Report date
2022-01-26
Termination date
2022-11-15
Voluntary/Mandated
Voluntary: Firm initiated
Location
Worcester, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0377-2022