Recall of hand sanitisers (Feb to April 2021)

Wholesale-level recall of hand sanitisers due to detection of acetaldehyde and/or methanol at levels above the pharmaceutical pharmacopoeia limit.

Date of Recall:

Feb to Apr 2021

Products:
  1. Asepso™ Professional Hand Sanitiser (Batch: B42M)
  2. Cuticura Hand Sanitizer (all batches)
  3. Epi KleenGel Hand Sanitizer Gel (all batches)
  4. Guardian Lavender & Passion Flower Antibacterial Hand Sanitiser (Batch: 9K28DF)
  5. Guardian Aloe & Korean-Mint Antibacterial Hand Sanitiser (Batch: 0D32DF)
  6. Kundal Fresh Water Hand Sanitizer+ (Batch: BN227)
  7. Sanitelle® Instant Hand Sanitizer Antiseptic Gel Kids (all batches)
  8. Cath Kidston® Moisturising Hand Sanitiser (all batches)
  9. 红月亮® Redmoon 抑菌免水净手凝胶 Bacteriostat Wash Free Hand Wash Gel (all batches)
  10. We11 Daily Instant Hand Sanitiser (all batches)
  11. Cool Day's Peppermint Instant Hand Sanitizer (all batches)
  12. Walch® Instant Hand Sanitizer (Batch: TG01)
  13. TP 706 Hand Sanitiser (Exp: 10/03/2022)
  14. Lifebuoy Instant Hand Sanitizer (Batch: OD13UL)
  15. FairPrice Hand Sanitiser Lavender (Batch: 201251-001)
  16. germ-X® Advanced Hand Sanitizer Original Scent (all batches)
  17. Sanigen Gel Hand Refreshing Gel 600ml (all batches)
  18. Yuri® Hand Gel Green Tea Extract (all batches)

Product Category:

Topical Antiseptics

Batch No:

Refer to Annex A

Class of Recall:

2

Level of Recall:

Wholesale

Local company:

Refer to Annex A

Description of Issue:

The product was tested under HSA’s product quality surveillance programme and was found to contain acetaldehyde and/or methanol at levels above the pharmaceutical pharmacopoeia limit

Recall Instructions:

Wholesale suppliers:

Stop supplying specified batches of the product 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’s 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 potentially cause 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.

 

Click on link below to view the list of affected products (Annex A):

Recall of hand sanitisers (Feb to April 2021)_Annex A486 KB

Healthcare professional, Industry member, Cosmetic products
Published:

Product Recalls