Sagent Pharmaceuticals is recalling 3 lots of Phenylephrine Hydrochloride Injection, USP (10mg/mL) due to potentially loose crimped vial overseals that may compromise the sterility of the product.
Phenylephrine Hydrochloride Injection is an alpha-1 adrenergic receptor agonist indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. According to the Company, “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 3 recalled lots of Phenylephrine Hydrochloride Injection, 10mg/mL (NDC Number 25021-315-01), were distributed nationwide to hospitals, wholesalers and distributors between November 17, 2020 to March 8, 2021 in 3mL glass tubular vials. The affected lots include:
- Lot Number PHT8IB2; Expiration Date 08/2022
- Lot Number PHT9IB2; Expiration Date 08/2022
- Lot Number PHT1JB2; Expiration Date 09/2022
To date, there have been no reported adverse events related to this recall. Any adverse events associated with the recall should be reported to the FDA’s MedWatch program.
For more information regarding the recall contact Sagent Pharmaceuticals by calling (866) 625-1618.
Sagent Pharmaceuticals, Inc. issues voluntary nationwide recall of Phenylephrine Hydrochloride Injection, USP, 10 mg/mL due to potential lack of sterility assurance. [press release]. Schaumburg, IL: Sagent Pharmaceuticals, Inc.; March 11, 2021.