Key Takeaway
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 Joa by Medichem S.A. was recalled on June 24, 2020. The hazard: Microbial contamination of Non-Sterile Product; detection of the gram-negative bacillus Serratia marcescens in certain API batches
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 Joa
Description
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
Hazard / Reason
Microbial contamination of Non-Sterile Product; detection of the gram-negative bacillus Serratia marcescens in certain API batches
Class I: Dangerous or defective product that could cause serious health problems or death.
Class I is the most serious recall classification used by the FDA, indicating a reasonable probability of serious health consequences or death.
Products Affected
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 Joa
DrugsDistribution
Nationwide
Related Recalls
Frequently Asked Questions
Is this recall still active?
Check the status badge at the top of this page. "Ongoing" means the recall is still active and you should follow the remedy instructions. "Completed" or "Terminated" means the recall process has concluded, though the safety issue remains relevant for any unrepaired products.
How do I check if my product is affected?
Compare the model number, lot code, serial number, or date range listed in the recall notice with the information on your product's label or packaging. For vehicles, check your VIN at NHTSA.gov/Recalls.
What remedy is available for this recall?
Check the remedy section above or contact the manufacturer directly for current remedy options.
Where can I find the original recall notice?
This recall was issued by FDA Drug. Visit the agency's official website for the original notice.