Medicine recalls
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| The United States: Recall: Baxter Initiates Voluntary Worldwide Recall Of Four Lots Of IV Solutions Due To The Presence Of Particulate Matter |
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Baxter International Inc. announced that it is voluntarily recalling four lots of intravenous (IV) solutions to the hospital/user level. These products include 0.9% Sodium Chloride 100 mL (Quad Pack) (lot no.: P298190), 0.9% Sodium Chloride 100 mL MINI-BAG Plus (lot no.: P308650), 0.9% Sodium Chloride, 50 mL (Single Pack) (lot no.: P309187), and Highly Concentrated Potassium Chloride Injection, 20 mEq/50 mL, VIAFLEX Plus Container (lot no.: P309476). These products have been found to contain particulate matter identified as cellulosic fibers and/or plastics. Baxter received four complaints over a period of six months from customers whose visual inspection identified the appearance of visible particulate matter prior to administration to a patient.
If infused, adverse health consequences of particulate matter could vary depending on the amount of particulate matter injected into the patient, the size of the particles, the patient’s underlying medical condition and the presence of a right-to-left cardiac shunt. The presence of particulate foreign matter may elicit inflammatory and allergic responses, both chronic and acute, and may be life threatening.
Sodium Chloride Injection, USP is an intravenously administered injectable indicated as a source of water and electrolytes, for use as a priming solution in hemodialysis procedures, and may be used as a diluent for reconstitution of a powdered drug product. Potassium Chloride Injection is an intravenously administered injectable indicated as a potassium replacement to support nerve conduction, muscle contraction and prevention of cardiac arrhythmias. The lots being recalled were distributed worldwide to customers and distributors between February 2013 and June 2014. There have been no reported adverse events associated with this issue to date, and an investigation is underway to determine root cause.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/Recalls/ucm405469.htm
In Hong Kong, Sodium Chloride Inj 0.9% (Baxter) (HK-20984) and 0.9% Sodium Chloride Injection, USP in Mini-Bag Plus Container (HK-61943) are pharmaceutical products which are registered by Baxter Healthcare Ltd. (Baxter). As confirmed with Baxter, Sodium Chloride Inj 0.9% (Baxter) (HK-20984) (lot no.: P309187) has been imported into Hong Kong from January to March 2014, and were distributed to private doctors and private and Hospital Authority hospitals. Baxter has already notified the Department of Health (DH) and initiated a recall of the concerned batch of product on 11 July 2014, and news release was issued by the Drug Office. Baxter has also issued a letter to Directors of Pharmacy to inform them of the recall on the same day. 0.9% Sodium Chloride Injection, USP in Mini-Bag Plus Container (HK-61943) (lot no.: P308650) has not been imported into Hong Kong. So far, the DH has not received any local report on the presence of particulate matter in the captioned products. The DH will monitor the recall and keep vigilant on the issue.
Ends/ Friday, July 18, 2014
Issued at HKT 14:00
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