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
Reported: September 2, 2020 Initiated: June 24, 2020 #D-1534-2020
Product 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
Reason for Recall
Microbial contamination of Non-Sterile Product; detection of the gram-negative bacillus Serratia marcescens in certain API batches
Details
- Recalling Firm
- Medichem S.A.
- Units Affected
- 117,800 kg
- Distribution
- Nationwide
- Location
- Barcelona, N/A
Frequently Asked Questions
What product 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. Recalled by Medichem S.A.. Units affected: 117,800 kg.
Why was this product recalled? ▼
Microbial contamination of Non-Sterile Product; detection of the gram-negative bacillus Serratia marcescens in certain API batches
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 2, 2020. Severity: Critical. Recall number: D-1534-2020.
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