Medicine recalls
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| The United States: Innoveix Pharmaceuticals, Inc. issues voluntary recall of all sterile compounded drug products due to a lack of sterility assurance |
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The US Food and Drug Administration (FDA) announces that Innoveix Pharmaceuticals, Inc. is voluntarily recalling all sterile compounded drug products, within expiry, to the consumer level. The products are being recalled due to a lack of assurance of sterility. These concerns arose following a routine inspection of the pharmacy by FDA.
Administration of a drug product intended to be sterile, that is not sterile, could result in serious infections which may be life-threatening. To date, Innoveix Pharmaceuticals, Inc. has not received any reports of adverse events related to this recall. This voluntary recall is being conducted out of an abundance of caution and to promote patient safety, which is the pharmacy's highest priority.
The affected products are injectable Human Chorionic Gonadotropin (HCG) and injectable Sermorelin w/GHRP2. The products can be used for various indications as prescribed. The products can be identified by an Innoveix Pharmaceuticals, Inc. label. Products were distributed to both customers and/or medical facilities. The affected products are:
- HCG 11,000 IUs
- HCG 5,000 IU's
- HCG 5,500 IU's
- Sermorelin w/GHRP2 3mg
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/innoveix-pharmaceuticals-inc-issues-voluntary-recall-all-sterile-compounded-drug-products-due-lack
In Hong Kong, the above products are not registered pharmaceutical products. There is also no registered pharmaceutical product manufactured by the above company.
Ends/Friday, Oct 11, 2019
Issued at HKT 15:00
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