Class I
Terminated
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
- Company
- Medichem S.A.
- Recall Initiated
- June 24, 2020
- Posted
- September 2, 2020
- Recall Number
- D-1534-2020
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 117,800 kg
- Firm Location
- Barcelona, Spain
Reason for Recall
Microbial contamination of Non-Sterile Product; detection of the gram-negative bacillus Serratia marcescens in certain API batches
Distribution
Nationwide
Lot / Code Info
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
More recalls by Medichem S.A.
Chlorhexidine Gluconate 20% 0012 Medichem, S.A. NDC 53296-0012-0
Nov 11, 2020 · Class II
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