Chlorhexidine Gluconate 0012 For Manufacturing recalled over sterility concerns

Recall date

June 24, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Medichem S.A. recalls Chlorhexidine Gluconate 0012 For Manufacturing, Processing or Repacking, RX Only, Medichem, S.A. Poligono Industrial Ce…

Recall number

D-1534-2020

FDA classification

Class I

Brand / firm

Medichem S.A.

Sold / distributed

Nationwide

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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