Reported Sep 2, 2020 · Terminated
Chlorhexidine Gluconate 0012 For Manufacturing, Processing or Repacking, RX Only, Medichem, S.A. Poligono Industrial…
Medichem S.A.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medichem S.A. · Fructuos Gelabert 6-8 · Barcelona, N/A · N/A
Is this the product you have?
- 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
- Lot codes and dates
A-190571exp. 11/29/21A-190418exp. 09/04/21A-190503exp. 10/25/21A-190576exp. 12/02/21A-190537exp. 11/15/21A-200082exp. 02/24/22A-200085exp. 02/25/22A-200097exp. 03/05/22A-200116exp. 03/13/22A-200127exp. 03/19/22A-200131exp. 03/20/22
- Amount recalled
- 117,800 kg
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
Microbial contamination of Non-Sterile Product; detection of the gram-negative bacillus Serratia marcescens in certain API batches
Using this product could cause serious injury, illness or death — stop using it now.
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