# FDA recall D-1534-2020

> **Medichem S.A.** · Class I · drug recall initiated 2020-06-24.

## 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

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1534-2020
- **Recalling firm:** Medichem S.A.
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-06-24
- **Report date:** 2020-09-02
- **Termination date:** 2021-04-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Barcelona, N/A, Spain

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1534-2020

## Citation

> AI Analytics. FDA recall D-1534-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-1534-2020. Source: US FDA. Licensed CC0.

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