FDA recall Z-1548-2020

Carroll-Baccari, Inc. · Class II · device

Product

LemonPrep Tubes (MD0019-T) and Single use cups (MD0019-SUP)

Reason for recall

Samples of 114gm tubes of Lemon Prep, collected during a Food and Drug Administration inspection on October 15, 2019 were tested and found to be contaminated with Burkholderia cepacia. Mavidon is recalling all products manufactured at their facility.

Distribution

Nationwide, Canada, UK, Spain, Australia

Key facts

Status
Terminated
Initiation date
2019-12-23
Report date
2020-04-01
Termination date
2021-09-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Riviera Beach, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1548-2020