Medicine recalls
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| The United States: FDA advises health care professionals not to use ChloraPrep 3 ml applicators manufactured by BD (Becton, Dickinson and Company) |
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The US Food and Drug Administration (FDA) advises health care professionals not to use ChloraPrep 3 ml applicators (chlorhexidine gluconate and isopropyl alcohol) manufactured by BD (Becton, Dickinson and Company), due to microbial contamination risks. The drug was distributed globally and is labeled with “CareFusion, El Paso, TX.”
BD’s investigation confirmed the product’s lid, when exposed to higher temperature and humidity, can fail and lead to microbial contamination which may cause serious infections, especially in patients with compromised immune systems.
This drug is used to sanitize skin prior to surgery or catheter procedures. Health care professionals should use an available alternative.
FDA recommended on 15 Mar 2021 that BD expand their recall (initiated in Jun 2020) to include all unexpired ChloraPrep 3 ml applicators in the United States. The company’s limited recall, which covered countries and the United States territories with tropical climates, was due to the lid defect after a finding of fungal growth that breached the product seal. To date, the company has not taken action to expand their recall and remove additional dangerous drugs from the United States market.
FDA is not aware of any adverse events associated with use of BD’s ChloraPrep 3 ml applicators.
Please refer to the following website in FDA for details:
http://www.fda.gov/drugs/drug-safety-and-availability/fda-advises-health-care-professionals-not-use-chloraprep-3-ml-applicators-manufactured-bd-becton
In Hong Kong, the above products are not registered pharmaceutical products. Related news was previously issued by Singapore Health Sciences Authority and FDA, and was posted on the Drug Office website on 27 Jul 2020, 11 Aug 2020 and 26 Aug 2020.
On 24 Jul 2020, the Department of Health (DH) endorsed a licensed wholesale dealer Becton Dickinson Asia Limited to recall all batches of "ChloraPrep One-Step 3ml Applicator - Clear" from the market due to potential growth of a fungus. A press statement was issued on the same date. The DH noted that the recall was completed.
Ends/Monday, Mar 22, 2021
Issued at HKT 15:00
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