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Public Alert No:007/2021 – Recall Of Phenylephrine Hydrochloride Injection Usp, 10mg/Ml By Sagent Pharmaceuticals Due To Potential Lack Of Sterility

March 25, 2021,

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.

PRODUCT LOT NUMBER EXPIRATION DATE NDC NUMBER DISTRIBUTION DATE
Phenylephrine Hydrochloride Injection, USP PHT8IB2 PHT9IB2 PHT1JB2 08/2022 08/2022 09/2022 25021-315-01 November 17, 2020 – March 8, 2021

Recommendations

NAFDAC implores importers, distributors, retailers, healthcare providers and patients in possession of the recall lots of injection to discontinue sale or use and handover stock to the nearest NAFDAC office.

Health professionals and patients are encouraged to report adverse events or quality problems experienced with the use of the products to the nearest NAFDAC office, NAFDAC PRASCOR [20543 or 0800-1-NAFDAC (0800-1-623322) TOLL FREE from all networks] or via 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.

NAFDAC……..Customer-focused, Agency-minded!!!

Signed Management

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