Agency classClass IOur severity:Critical FDA (Drugs)·D-1534-2020·Announced 2020-09-02

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.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. 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.
Category: Drug — Active Pharmaceutical Ingredient
Hazard: microbial-contamination
seratia-marcescens

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.

Same manufacturer · Medichem S.A.

See all →

Moderate
Medichem Recalls Chlorhexidine Gluconate 20% Due to Discoloration
FDA (Drugs) · 2020-11-11

Same hazard · microbial contamination