FDA-Drug2020-09-02Class I
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
Medichem S.A.
Hazard
Microbial contamination of Non-Sterile Product; detection of the gram-negative bacillus Serratia marcescens in certain API batches
Sold states
Nationwide
Affected count
117,800 kg
Manufactured in
Fructuos Gelabert 6-8, N/A, Barcelona, N/A, Spain
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1534-2020Don't want to check this manually?
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