Medicine recalls
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| The United States: Ranier’s Rx Laboratory issues voluntary recall of all sterile compounded products within expiry due to lack of sterility concerns |
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The US Food and Drug Administration (FDA) announces that Ranier’s Rx Laboratory is voluntarily recalling all sterile compounded drug products within expiry to the hospital or consumer level.
These drug products are being voluntarily recalled due to concerns that practices at the pharmacy have the potential to pose a risk of contamination to products that are intended to be sterile. These concerns arose following a routine inspection of the pharmacy by FDA.
The recall encompasses compounded sterile drug products, within expiry, that were dispensed between 17 Jan 2018, and 10 Jul 2018. The sterile drug products subject to this recall were distributed only within the State of Pennsylvania and directly to customers and/or medical facilities. The recall does not affect the pharmacy’s non-sterile compounded products or retail pharmacy operations.
Administration of a non-sterile product that is intended to be sterile by subcutaneous, intramuscular, intravenous or ocular routes of administration may result in a site-specific or systemic infection which in turn may result in hospitalization, significant morbidity, organ damage, or a fatal outcome. The pharmacy has not received any reports of patient complaints or adverse events related to this recall. To date, FDA is not aware of any adverse events associated with the use of compounded drug products from the pharmacy. Nor is there any indication that the compounded sterile drug products being recalled are actually contaminated. This voluntary recall is being conducted out of an abundance of caution and to promote patient safety, which is the pharmacy’s highest priority.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/Recalls/ucm615054.htm
In Hong Kong, there is no registered pharmaceutical product manufactured by the above company. Related news was previously issued by FDA, and was posted on the Drug Office website on 12 Jul 2018.
Ends/Monday, Jul 30, 2018
Issued at HKT 15:00
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