FDA recall D-0290-2022

Efficient Laboratories, Inc. · Class II · drug

Product

Rompe Pecho CF Cold & Flu Advanced Formula, 6 Fl. oz. (178 mL) bottles, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166, NDC 58593-235-06

Reason for recall

Microbial Contamination of Non-Sterile Products

Distribution

Nationwide within the United States

Key facts

Status
Terminated
Initiation date
2021-08-24
Report date
2021-12-29
Termination date
2022-12-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Miami, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0290-2022