Medicine recalls
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| The United States: B. Braun Medical issues voluntary nationwide recall of Lactated Ringer’s Injection USP 1000 mL and 0.9% Sodium Chloride Injection USP 1000 mL due to the presence of particulate matter |
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The US Food and Drug Administration (FDA) announces that B. Braun Medical Inc. (B. Braun) is voluntarily recalling two lots of Lactated Ringers Injection USP 1000 mL (lot number: J4S807), and 0.9% Sodium Chloride Injection USP 1000 mL (lot number: V3K770) to the hospital level due to the presence of particulate matter inside the container.
B. Braun has identified through complaints the potential for the product to contain particulate matter in solution. To date there have been no reports of serious injury, death or other adverse events associated with this issue. If the particulate matter is observed before use, a minor delay could occur while obtaining a replacement product. If the particulate matter is loose and the container is used on a patient, there is a potential for the particulate to be infused into the circulatory system. This could lead to patient harm that may require additional medical intervention and/or lead to permanent impairment or death.
The product has a reasonable probability of causing pulmonary emboli (blockage in pulmonary blood vessels), occlusions of other blood vessels (which can lead to tissue death and possible organ damage), and/or phlebitis (inflammation of the walls of veins, which may lead to clotting). Systemically, foreign particles infused intravenously can cause systemic activation of the immune system, organ dysfunction, and hemolysis (breakdown of blood cells). The product is indicated for use as a source of electrolytes and water for hydration.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/b-braun-medical-issues-voluntary-nationwide-recall-lactated-ringers-injection-usp-1000-ml-and-09
In Hong Kong, Sodium Chloride Inj 0.9% (B Braun) (HK-28240), Sodium Chloride Inj 0.9% (B. Braun) (HK-44881), Sodium Chloride Solution For Infusion 0.9% w/v (HK-66001), Compound Sodium Lactate Inj (Hartmann's) (HK-28245) and Compound Sodium Lactate Hartmann's Soln IV Inf (HK-55732) are pharmaceutical products registered by B. Braun Medical (HK) Ltd (B. Braun HK). All products are prescription-only medicines. As confirmed by B. Braun HK, the affected lots have not been imported into Hong Kong. Related news was previously issued by FDA, and was posted on the Drug Office website on 9 Aug 2024.
Ends/Wednesday, Aug 20, 2025
Issued at HKT 16:30
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