FDA alert for alcohol pads and antiseptic towelettes made by Foshan Flying Medical Products

Published: 11-Sep-2017
Cleaning

The US FDA is concerned over a lack of sterility assurance and other quality issues with specific products made by the Chinese company from Foshan City, Guangdong Provence

The US Food and Drug Administration is alerting healthcare professionals and patients not to use alcohol pads or benzalkonium chloride antiseptic towelettes made by Foshan Flying Medical Products Co Ltd, located in China, due to the lack of sterility assurance and other quality issues.

These products are distributed by Total Resources International, Walnut, California, and Simple Diagnostics Inc, Williston Park, New York. The use of these alcohol pads and antiseptic towelettes could cause infections.

The FDA initially contacted Foshan on May 25, 2017, regarding a recall, and had several follow-up meetings with the company. However, Foshan has not taken action to remove its alcohol pads or antiseptic towelettes from the market.

FDA placed all drug products made by Foshan on import alert on May 23, 2107, to stop these products from entering the US. However, FDA is concerned these products might still be in US distribution. FDA also sent Foshan a warning letter on August 1, 2017, for violations of current good manufacturing practice regulations.

Patients, healthcare facilities and pharmacies that have alcohol pads and antiseptic towelettes labeled by Total Resource or Simple Diagnostics should immediately stop using them and discard the products.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.

  • Companies:
  • US Food and Drug Administration (FDA)
See more

You may also like

Regulatory

Warning Letters: Lessons from an FDA Captain

Read more
Redica Systems’ Jerry Chapman talks to FDA's Ileana Barreto-Pettit

Trending Articles

  1. You need to be a subscriber to read this article.
    Click here to find out more.
    What is ISO 8 cleanroom classification? Each cleanroom class is denoted by a maximum concentration of particles per cubic meter or cubic foot of air. ISO 8 is the second lowest cleanroom classification
  2. Sterile transfer expert ABC Transfer chooses exclusive distributor in Italy Amira has been chosen by ABC to be the exclusive distributor of ABC Transfer Rapid Transfer Port products in Italy
  3. The details of dust extraction in controlled environments To choose the right machine, the nature of the dust and the statutory regulations for its handling and removal, as well as classification of the machine and filter technology, must be considered. Daniel Took from archer reminds us, the lower the Threshold Limit Value (TLV) for dust, the higher the health risk
  4. Electrolux Professional unveils new series of high capacity barrier washers for hygiene-critical applications Electrolux Professional has announced the launch of its new Line 6000 Pullman series of high-capacity barrier washers, offering unparalleled hygienic protection for use in a broad range of sensitive environments
  5. You need to be a subscriber to read this article.
    Click here to find out more.
    Battling biofilms in cleanrooms Michelle Locke from Teknomek discusses how it is possible to combat the persistent threat of biofilms with the right cleanroom furniture, equipment, and cleaning protocols

Upcoming event

EMPQ Essentials and Real-World Strategies for Successful Cleanroom Qualifications

16 January 2025 | Virtual See all

You may also like

Regulatory

Warning Letters: Lessons from an FDA Captain

Redica Systems’ Jerry Chapman talks to FDA's Ileana Barreto-Pettit
Regulatory

FDA gives out 483 form to Torrent Pharma citing "inadaquate cleaning procedure"

The pharma giant from India has been give the form citing three main issues
Cleaning

Study finds $1 per reaction LAMP assay works for BCC testing

The novel assay has been assessed for detecting the bacteria responsible for many pharmaceutical product recalls, Burkholderia cepacia complex
Cleaning

Understanding cleanroom behaviours in compounding pharmacies

Protecting patients from poor-quality compounded drugs is a fundamental part of the US Food and Drug Administration’s (FDA) drug compounding programme and the pharmacies must adhere to strict cleanliness standards. FDA Microbiologist, Djamila Harouaka, explains
Regulatory

FDA recommends Eskbiochem recall hand sanitiser with 81% methanol

The FDA has advised consumers to not use hand sanitiser manufactured by Eskbiochem in Mexico due to the potential for methanol poisoning
Cleaning

Custom Ultrasonics passes FDA validation of automated endoscope reprocessors

The US Food and Drug Administration has determined that the System 83 Plus AERs may now be used to reprocess only the Olympus TJF-Q180V duodenoscope and the Pentax ED-3490TK duodenoscope
Regulatory

FDA proposes to recall Cantrell Drug products

The US Food and Drug Association has reported deficiencies in quality and sterility of compounded drug products at the Cantrell Drug Company facilities
Subscribe now