Nigerian News | NAFDAC Recalls Phenylephrine Hydrochloride Injection Due to Potential Lack of Sterility

NAFDAC
Image Credit: © NLIPW

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 which 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 products, 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

NAFDAC reportedly implored importers, distributors, retailers, healthcare providers, and patients in possession of the recall lots of injection to discontinue sale or use and hand overstock to the nearest NAFDAC office.

The agency reportedly advised 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. 

Print Friendly, PDF & Email
FILE A TRADEMARK
About Nathaniel Adebayo 689 Articles
Nathaniel is a News Reporting Intern at Nigerian Law Intellectual Property Watch (NLIPW). He has a passion for writing, capacity building and social media marketing. He is a graduate of Federal University of Technology, Minna, where he graduated with BTECHAGRIC. He is a member of Soil Science Society of Nigeria (SSSN) and the National Union of Campus Journalist (NUCJ). Nathaniel has served as Editor-in-Chief for a number of magazines and as a contributor to various online repositories. Email: anathaniel@nlipw.com

Be the first to comment

Leave a Reply

Your email address will not be published.




This site uses Akismet to reduce spam. Learn how your comment data is processed.