The Therapeutic Goods Administration (TGA) announced that Boehringer Ingelheim Pty Ltd is recalling twelve batches of IMUKIN interferin gamma-1b recombinant human 2 million IU(100 micrograms)/0.5mL injection vial to retail level. The affected batches are 301147C, 301147B, 301147A, 301147, 204754E, 204754D, 204754C, 204754B, 204754A, 204754, 202794A and 202794. During on-going stability studies for the product at 12 months, out of specification results have been detected for the above batches. Boehringer Ingelheim is advising users to discontinue use of the affected batches.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/../arn-detail.aspx?k=RC-2014-RN-00113-1
In Hong Kong, Boehringer Ingelheim (HK) Ltd (Boehringer) registered the interferon gamma-containing product as Immukin Injection 100mcg/0.5ml (HK-43554). According to Boehringer, only the batch of 301147B among those affected batches was imported into Hong Kong and has never been distributed to the Hong Kong market. DH will keep vigilant on any safety information related to the product
Ends/ Tuesday, February 04, 2014
Issued at HKT 16:00
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