Medicine recalls
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| The United States: Staska Pharmaceuticals, Inc. issues voluntary nationwide recall of Ascorbic Acid Solution for Injection (Preservative Free, Non-Corn) 500mg/mL due to the presence of glass particles |
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The US Food and Drug Administration (FDA) announces that Bennet, NE, Staska Pharmaceuticals, Inc. is voluntarily recalling one lot of Ascorbic Acid Solution for Injection (Preservative Free, Non-Corn) 500mg/mL, 50mL vials (lot number: SP2400058) to the user level. This is due to the presence of glass particulates in one lot of vials used in the production of this batch.
The administration of an injectable product containing particulate matter may result in local irritation or swelling. The particulate matter could travel through and block blood vessels in the heart, lungs or brain which can cause stroke and even lead to death. The frequency and severity of these adverse events could vary depending upon a variety of factors including the size and number of particles in the drug product, patient comorbidities, and the presence or absence of vascular anomalies.
To date, Staska Pharmaceuticals has not received any reports of the presence of particulate matter, nor any adverse events related to this recall. This risk is further reduced as the product label contains a clear statement directing the healthcare professional to visually inspect the product for foreign particulate matter or precipitate before administering.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/staska-pharmaceuticals-inc-issues-voluntary-nationwide-recall-ascorbic-acid-solution-injection
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Thursday, Oct 17, 2024
Issued at HKT 15:30
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