FDA recall D-1534-2020

Product

Chlorhexidine Gluconate 0012 For Manufacturing, Processing or Repacking, RX Only, Medichem, S.A. Poligono Industrial Celra, 17460, Celra, Girona (Spain/Espana); Fructuos Gelabert, 6-8, 08970, Sant Joan Despi, Barcelona (Spain/Espana) NDC 53296-0012-0

Reason for recall

Microbial contamination of Non-Sterile Product; detection of the gram-negative bacillus Serratia marcescens in certain API batches

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2020-06-24

Report date

2020-09-02

Termination date

2021-04-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Barcelona, N/A, Spain

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1534-2020