Recall of ChloraPrep® One-Step - 3 mL applicator clear and ChloraPrep® With Tint - 3 mL Applicator - Hi-Lite Orange

Retail-level recall of ChloraPrep One-Step - 3 mL applicator clear and ChloraPrep With Tint - 3 mL Applicator - Hi-Lite Orange due to potential for microbial contamination.

Date:	17 July 2020
Product:	ChloraPrep® One-Step - 3 mL applicator clear and ChloraPrep® With Tint - 3 mL Applicator - Hi-Lite Orange
Active Ingredient:	Chlorhexidine gluconate and isopropyl alcohol
Product Category:	Therapeutic product
Batch No.:	ChloraPrep® One-Step - 3 mL applicator clear 48062 8165721 9015917 9060734 9080812 9156866 9206555 9236531 9280666 ChloraPrep® With Tint - 3 mL Applicator - Hi-Lite Orange 11737 44734 9053560 9137903 9154908 9218595 9257903 9291279
Class of Recall:	2
Level of Recall:	Retail
Local Company:	Becton Dickinson Holdings Pte Ltd
Description of Issue:	This recall is a precautionary measure following the detection of Aspergillus penicillioides in the affected batches of ChloraPrep® 3mL.
Recall Instructions:	Hospitals: Stop supplying the affected batches and return the remaining stocks to the company.

 

Note:

The Health Sciences Authority (HSA) publishes information regarding recalls of health products supplied in Singapore. These product recalls may be conducted on a company’s own initiative or upon HSA request to remove products where there are issues with quality, safety or efficacy.

When a recall is initiated, it does not necessarily imply that a product is considered unsafe or is inefficacious. A recall can also be initiated to remove products with quality defects that does not impact safety or efficacy from the market so as to ensure that products registered in Singapore continue to meet the stringent regulatory standards stipulated by HSA.

Not all recalls will lead to press releases. However, when a recall involves a product that has been widely distributed or a product that poses a serious health risk, HSA will issue a press release to inform members of public.

 

Class of recall

A recall is classified as Class 1 or Class 2 depending on the potential hazard of the issue.

• Class 1: For recalls of products with issues that can potentiallycause serious adverse health outcomes or death.
• Class 2: For recalls of products with issues that would not likely cause serious adverse health outcomes.

 

Level of recall

The level of product recall will depend on the potential hazard of the affected product, extent of distribution and whether other mitigating measures can be taken to address the issue.

1. Consumer level: Affected product or batch(es) recalled from patients and consumers as well as wholesale suppliers, retail suppliers, hospitals, clinics and pharmacies.
2. Retail level: Affected product or batch(es) recalled from retail suppliers, hospitals, clinics and pharmacies as well as wholesale suppliers.
3. Wholesale level: Affected product or batch(es) recalled from wholesale suppliers.

Published: 17 Jul 2020

Product Recalls