Class II · Moderate risk
2% Chlorhexidine Gluconate* Cloth
Cross Contamination with Other Products
Chlorhexidine Gluconate 0012 For Manufacturing
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Microbial contamination of Non-Sterile Product; detection of the gram-negative bacillus Serratia marcescens in certain API batches
Cause type: Microbial contamination
Bacteria, mold, yeast or other microorganisms detected in the product. Contamination can occur from water systems, equipment or handling, and can cause infection. All microbial contamination recalls.
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
Affected NDC
53296-0012-00
Compare with the code on your package — it is the most precise check available.
Drug: Chlorhexidine
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Chlorhexidine Gluconate NDC 53296-0012 |
200 kg/1000kg | Solution | Medichem S.A. | DRUG FOR FURTHER PROCESSING |
- Recalling firm
- Medichem S.A.
- NDC code
- 53296-0012-0
- Origin
- N/A, Spain
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1534-2020 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Chlorhexidine recalls
See all
Class II · Moderate risk
BD ChloraPrep Clear
Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicator
Class II · Moderate risk
BD ChloraPrep CLear
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Class II · Moderate risk
BD ChloraPrep CLear
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Class II · Moderate risk
BD ChloraPrep Scrub Teal
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Other recalls by Medichem S.A.
All 2020 recalls
Class II · Moderate risk
Chlorhexidine Gluconate 20% 0012 Medichem
Discoloration.
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