Medicine recalls
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| The United States: BD issues nationwide recall for specific lots of ChloraPrep™ Clear Single Sterile 1 mL and FREPP™ Clear 1.5 mL Applicators due to microbial contamination |
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The US Food and Drug Administration (FDA) announces that BD (Becton, Dickinson and Company) is voluntarily recalling lot 4032183 of ChloraPrep™ Clear 1 mL Single Sterile and lot 4073005 of ChloraPrep™ FREPP™ Clear 1.5 mL applicators with paper lidding (chlorhexidine gluconate 2% w/v, isopropyl alcohol 70% v/v) to the consumer level. These products are being recalled due to fungal contamination under certain environmental conditions allowing the growth of Aspergillus penicillioides.
Contamination of skin preparation products with Aspergillus penicillioides may lead to serious systemic infection, sepsis, illness, and death. If the fungus is introduced in the patient’s bloodstream during placement of an intravascular catheter, the catheter would most likely have to be removed, necessitating another procedure. Aspergillus penicillioides infection of a surgical site may result in the need for medical and surgical interventions and long-term treatment with antifungal drugs. Importantly, BD has not received any reports of adverse events related to this recall.
In addition, BD is recalling other lots out of an abundance of caution as outlined in the customer letter in the FDA website.
These products are packaged in a pouch with paper lidding and used for the preparation of the patient’s skin prior to procedures, to help reduce bacteria that potentially can cause skin infection.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bd-issues-nationwide-recall-specific-lots-chlorapreptm-clear-single-sterile-1-ml-and-frepptm-clear
In Hong Kong, the above products are not registered pharmaceutical products. Related news was previously issued by FDA and Health Canada, and was posted on the Drug Office website on 19 Feb 2025.
Ends/Tuesday, Jun 9, 2026
Issued at HKT 16:15
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