FDA recall D-0292-2022

Product

Rompe Pecho Ex Expectorant, packaged in a) 4 Fl. Oz. (118 mL) bottles NDC 58593-829-04 and b) 6 Fl. Oz. (178 mL) bottles NDC 58593-829-06, Distributed by Efficient Laboratories, Inc. Miami, FL 33166

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-0292-2022