Medichem S.A. recalls Chlorhexidine Gluconate 0012 For Manufacturing, Processing or Repacking, RX Only, Medichem, S.A. Poligono Industrial Cel
Recalled September 2, 2020 · FDA recall D-1534-2020 · Medichem S.A
Hazard
Microbial contamination of Non-Sterile Product; detection of the gram-negative bacillus Serratia marcescens in certain API batches · FDA Class I
Units
117,800 kg
Sold at
Nationwide
Description
Microbial contamination of Non-Sterile Product; detection of the gram-negative bacillus Serratia marcescens in certain API batches
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
Manufacturer(s)
Medichem S.A.
Made in
Spain
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →