Drug 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
D-1534-2020
Product summary
- Firm
- Medichem S.A.
- Event
- Event 85869
- Status
- Terminated
- Classification
- Class I
- Quantity
- 117,800 kg
- Official record key
drug-enforcement:D-1534-2020
Official wording
Reason: Microbial contamination of Non-Sterile Product; detection of the gram-negative bacillus Serratia marcescens in certain API batches
Code information: 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
Distribution pattern: Nationwide
Derived failure modes
-
Microbial contamination
Microbial contamination