Medicine recalls
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| The United States: Provepharm Inc. issues voluntary nationwide recall of one lot of Phenylephrine Hydrochloride Injection, USP, 10 mg/ mL (Pharmacy Bulk Package) due to presence of particulate matter |
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The United States Food and Drug Administration (FDA) announces that Collegeville, Pennsylvania, Provepharm Inc. is voluntarily recalling lot number 24020027; Expiry Date December 2025 of Phenylephrine hydrochloride Injection, USP, 10 mg/ mL (Pharmacy Bulk Package) at the hospital/institutional level. This recall was initiated based on a customer complaint from a pharmacy after observing a visible black particulate matter found in a single-sealed vial of the product.
Administration of an injectable product containing particulate matter may cause local irritation or swelling as a response to the foreign material. If the particulate matter enters the blood vessels, it can travel to various organs and potentially blocking blood vessels in the heart, lungs or brain, leading to serious complications such as stroke or even death. To date, Provepharm Inc. has not received any reports of adverse events or injuries associated with this recall.
Phenylephrine hydrochloride Injection is used for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/provepharm-inc-issues-voluntary-nationwide-recall-one-lot-phenylephrine-hydrochloride-injection-usp
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Saturday, Jan 25, 2025
Issued at HKT 12:00
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