Sagent voluntarily recalls phenylephrine hydrochloride vials

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.

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