Medicine recalls
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| The United States: Hospira issues a voluntary nationwide recall for one lot of Sterile Water for Injection, USP, due to the potential presence of visible particulate |
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The US Food and Drug Administration (FDA) announces that Hospira, Inc., a Pfizer company, is voluntarily recalling lot DN9185 of Sterile Water for Injection, USP, 100 ml Single Dose Glass Fliptop Vial, to the hospital/institution level due to a confirmed customer report for a single vial with a visible particulate.
Hospira’s assessment of the potential risk to patients concluded that in rare instances the use of the impacted product can be associated with potential adverse events such as anaphylaxis, fever, gastrointestinal disturbances, vein irritation, localized vein inflammation, phlebitis, end-organ granuloma, tissue ischemia, pulmonary emboli, and infarction. To date, Hospira, Inc. has not received reports of any adverse events associated with this issue for this lot.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/hospira-issues-voluntary-nationwide-recall-one-lot-sterile-water-injection-usp-due-potential
In Hong Kong, there is one water for injection product registered by Pfizer Corporation Hong Kong Limited (Pfizer), namely Water For Inj BP 100ml (HK-36425), and is a prescription-only medicine. As confirmed with Pfizer, there is no importation of the above product.
Ends/Wednesday, May 5, 2021
Issued at HKT 16:00
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