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.


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For more information regarding the recall contact Sagent Pharmaceuticals by calling (866) 625-1618.

Reference

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.