D-1534-2020 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- September 2, 2020
- Initiation Date
- June 24, 2020
- Termination Date
- April 9, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 117,800 kg
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
Distribution Pattern
Nationwide
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