Product recalls and adverse events
The Therapeutic Goods Administration is urgently investigating reports from Queensland Health of adverse events associated with the use of Peripherally Inserted Central Catheter (PICC) lines in Queensland. The TGA is also working with the sponsor of the Arrow brand catheter to ascertain whether their instructions for use and labelling provide adequate information to the user to minimise reoccurrence of the type of problem described in the reports.
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On 2 October Nutrex Research Lipo 6 liquid capsules (Batch 10001277, exp 09/10) were issued a Class II Recall due to some bottles of this product containing traces of yohimbine. (Sponsor – Export Corporation, trading as Nutrition Systems)
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On 15 September Blackmores Sustained Release C tablets, 200s (Aust L 119710, batches A7559-2, exp04/10; A7958-2, exp04/10; A7959-2, exp02/10) were issued a Class III Recall as some bottles containing Bio C Chewable tablets (500mg Vitamin C) have been labelled as Sustained Release C tablets (500mg Vitamin C). (Sponsor – Blackmores Ltd)
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In September a number of hot/cold gel packs were issued Class I Recalls due to the products containing the toxic substance ethylene glycol rather than the non-toxic ingredient propylene glycol. For list of products involved click here.
[Class I defects are potentially life-threatening or could cause a serious risk to health.
Class II defects could cause illness or mistreatment, but are not Class I.
Class III defects may not pose a significant hazard to health, but withdrawal may be initiated for other reasons.]
TGO 77 – Microbiological standards for medicines
An on-line version of Therapeutic Goods Order No 77 Microbiological Standards for Medicines (TGO 77) is available as well as a guidance document, intended to provide a plain English explanation of various requirements of TGO 77 and their application, in order to assist sponsors with compliance.
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TGA online services
TGA Online Services will be unavailable to all users from COB 29 October 2008 to COB 4 November 2008 AEDT inclusive. The TGA is currently preparing the imminent release of an upgraded version of the Online Services Internet site the TGA eBusinessServices (eBS) which will replace the current, multi-point access, Online Services interface (SIME).
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Uniform recall procedure for therapeutic goods – updated contacts
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Client details form - updated
This form should be completed by each client involved with the supply of the therapeutic goods in Australia for which the TGA requires address details.
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Newly published European guidelines
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