Medicine recalls
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| The United States: GFA Production (Xiamen) Co., Ltd. issues voluntary nationwide recall of Easy Care First Aid® AfterBurn® Cream and First Aid kits due to microbial contamination |
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The US Food and Drug Administration (FDA) announces that GFA Production (Xiamen) Co., Ltd. is voluntarily recalling one lot of Easy Care First Aid® AfterBurn® Cream 0.9 g single-use packets (benzalkonium chloride, lidocaine) (lot number: W06I28). The single-use packets are sold in boxes of 10 or packaged in certain First Aid kits. This recall is to the consumer level. FDA analysis found the product to be contaminated with Bacillus licheniformis and Bacillus sonorensis.
In immunocompromised patients, the topical use of the contaminated Easy Care First Aid® AfterBurn® Cream 0.9 g single-use packets could potentially result in severe or life-threatening adverse events such as bacteremia, sepsis, and peritonitis. In non-immunocompromised patients, the population most likely to use the product, the use of the defective product may result in infectious complications, for instance skin infections, but in this population the infections are expected to be less severe and more readily responsive to treatment. To date, GFA Production (Xiamen) Co., Ltd. has not received any reports of adverse events related to this recall.
The Easy Care First Aid® AfterBurn® Cream 0.9 g single-use packet is used as an over the counter first-aid treatment for minor burns. The single-use packets bear lot number W06I28 and are packaged in boxes of 10 or included in the certain First Aid kits. For details of the affected First Aid kits, please refer to the website in FDA.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/gfa-production-xiamen-co-ltd-issues-voluntary-nationwide-recall-easy-care-first-aidr-burn-cream-and
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Wednesday, Dec 28, 2022
Issued at HKT 16:00
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