Barcelona, N/A, Spain
Medichem S.A. recalls
2 recalls recorded since 2018, most recently on 2 October 2020. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)0
Terminated or completed2
Class I (FDA)1
Terminated Class II Drugs
- Recall started
- 2 October 2020
- Terminated
- 16 December 2020
- Reason
- Discoloration.
- Distribution
- AL, NJ, TX
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0055-2021
- Chlorhexidine Gluconate 20% 0012 Medichem, S.A. NDC 53296-0012-0
Terminated Class I Drugs
- Recall started
- 24 June 2020
- Terminated
- 9 April 2021
- Reason
- Microbial contamination of Non-Sterile Product; detection of the gram-negative bacillus Serratia marcescens in certain API batches
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- 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 (
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.