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 email@example.com.