FDA Recall D-1534-2020

Medichem S.A. · Barcelona, N/A

Class I — life-threatening Terminated 289 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

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

Lot / code: 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

Quantity: 117,800 kg

Reason for recall

Microbial contamination of Non-Sterile Product; detection of the gram-negative bacillus Serratia marcescens in certain API batches

Recall record

Recall number: D-1534-2020
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide
Recall initiated: 2020-06-24
Classified by FDA Center: 2020-08-21
FDA published: 2020-09-02
Terminated: 2021-04-09
Recalling firm: Medichem S.A.
Firm location: Barcelona, N/A, Spain

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