Sagent issues voluntary recall of phenylephrine hydrochloride vials

By Jenni Spinner contact

- Last updated on GMT

(Adisonpk/iStock via Getty Images Plus)
(Adisonpk/iStock via Getty Images Plus)

Related tags: Fda, Recall, Vials, Injectables, Regulation

The company is recalling 10 mg/mL vials of phenylephrine hydrochloride due to potential lack of sterility assurance in several lots of the product.

Sagent Pharmaceuticals has announced the voluntary US-wide recall of three lots of Phenylephrine Hydrochloride Injection, USP (10 mg/mL). Recall of the product (manufactured by Indoco Remedies and distributed by Sagent) was initiated by Sagent after hearing customer complaints about potentially loose crimped vial overseals; a non-integral crimped vial overseal may result in a non-sterile product.

According to the US Food and Drug Administration (FDA), intravenous administration of a product intended to be sterile that is not actually sterile could result in serious systemic infections, which could end up being life-threatening. 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 US:

  • Product: Phenylephrine Hydrochloride Injection, USP           
  • Lot numbers: PHT8IB2, PHT9IB2, PHT1JB2
  • Expiration dates: 08/2022, 08/2022, 09/2022
  • NDC number: 25021-315-01
  • Distribution dates: November 17, 2020 – March 8, 2021

Customers are being notified by fax, email, FedEx, and/or certified mail to make arrangements for the return of all recalled products. Customers have been instructed to examine their inventory immediately and to quarantine, discontinue distribution of and return the recalled lots listed above.

Customers who may have further distributed this product have been requested to identify their customers and notify them at once of this product recall. Consumers/distributors/retailers that have product that is being recalled should stop using the product and return the recalled product. The necessary form by which to document this information, as well as other information regarding this recall, is available at www.SagentPharma.com.

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