The National Agency for Food and Drug Administration and Control (NAFDAC) has implored importers, distributors, retailers, healthcare providers and patients in possession of phenylephrine hydrochloride injection by Sagent Pharmaceuticals to discontinue sale or use and handover stock to the nearest NAFDAC office.
Contained in a statement by the agency on its official website, NAFDAC gave reasons for the urgent recall of the injections.
According to the statement, “The National Agency for Food and Drug Administration and Control (NAFDAC) has been informed by U.S Food and Drug Administration that Sagent Pharmaceuticals is recalling three lots (PHT8IB2 PHT9IB2 PHT1JB2) of PHENYLEPHRINE HYDROCHLORIDE INJECTION USP, 10mg/ml due to potentially loose crimped vial overseals.
“A non-integral crimped vial overseal may result in a non-sterile product.
“Intravenous administration of a product intended to be sterile that is not sterile could result in serious systemic infections which may be life-threatening.
“The possibility of a breach in sterility assurance in distributed product, while remote, cannot be eliminated. To date, Sagent has not received reports of any adverse events associated with this issue.
“Phenylephrine Hydrochloride Injection, USP is an alpha-1 adrenergic receptor agonist indicated for the treatment of clinically important low blood pressure resulting primarily from the dilation of blood vessels, which decreases blood pressure in the setting of anesthesia.
“The product is supplied in 3 ml glass tubular vials. The lot numbers being recalled were distributed to hospitals, wholesalers and distributors nationwide in the USA from 11/17/2020 – 03/08/2021.” It stated.
NAFDAC, further encouraged health professionals and patients to report adverse events or quality problems experienced with the use of the products to the nearest NAFDAC office, or via email @ pharmacovigilance@nafdac.gov.ng or via eReporting platform available on the NAFDAC website www.nafdac.gov.ng or via Med Safety Application available for download on Android and IOS stores.
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