Chlorhexidine Gluconate 0012 For Manufacturing — Class I drug recall D-1534-2020
Terminated recall by Medichem S.A., reported 2020-09-02, distributed nationwide. Microbial contamination of Non-Sterile Product; detection of the gram-negative bacillus Serratia marcescens in
| Recall number | D-1534-2020 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medichem S.A., Barcelona, N/A, Spain |
| Recall initiated | 2020-06-24 |
| Classified | 2020-08-21 |
| Reported by FDA | 2020-09-02 |
| Terminated | 2021-04-09 |
| Distributed | Nationwide (US) |
| Quantity | 117,800 kilograms |
| Reason classes | microbial contamination, sterility |
| NDC | 53296-0012-00 |
| Expiration dates | 2021-09-04, 2021-10-25, 2021-11-15, 2021-11-29, 2021-12-02, 2022-02-24, 2022-02-25, 2022-03-05, 2022-03-13, 2022-03-19, 2022-03-20 |
Product
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
Reason for recall
Microbial contamination of Non-Sterile Product; detection of the gram-negative bacillus Serratia marcescens in certain API batches
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1534-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.