FDAFDA · Food and drugs·Recall number D-1534-2020
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
Published September 2, 2020 · Recall initiated: June 24, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Microbial contamination of Non-Sterile Product; detection of the gram-negative bacillus Serratia marcescens in certain API batches
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medichem S.A.
- Distributor
- Nationwide
- Lot
- A-190571, exp. 11/29/21, A-190418, exp. 09/04/21, A-190503, exp. 10/25/21, A-190576, exp. 12/02/21, A-190537, exp. 11/15/21, A-200082, exp. 02/24/22, A-200085, exp. 02/25/22, A-200097, exp. 03/05/22, A-200116, exp. 03/13/22, A-200127, exp. 03/19/22, A-200131, exp. 03/20/22
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- Spain
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