Medichem Recalls Chlorhexidine Gluconate Due to Serratia marcescens Contamination
Medichem S.A. is recalling Chlorhexidine Gluconate 0012 for manufacturing due to microbial contamination with Serratia marcescens.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which indicates a reasonable probability that use of or exposure to the violative product will cause serious adverse health consequences or death.
Plain-English summary
Medichem S.A. is recalling Chlorhexidine Gluconate 0012, an active pharmaceutical ingredient (API) intended for manufacturing, processing, or repacking. The recall involves 117,800 kg of the product, which is distributed nationwide. The specific lot numbers and expiration dates affected are listed in the recall documentation.
The recall was initiated because of microbial contamination in certain API batches. Specifically, the gram-negative bacillus Serratia marcescens was detected in the non-sterile product. This contamination poses a risk of infection or other adverse health effects if the contaminated material is used in the production of final pharmaceutical products.
Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed in the recall notice. If the product is found, it should be quarantined and not used. Recalling firm Medichem S.A. is responsible for managing the recall and providing further instructions to affected parties.
The recalled product
- 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
- Manufacturer
- Medichem S.A.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
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