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MedWatch – The FDA Safety Information and Adverse Event Reporting Program
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TOPIC: Phenylephrine Hydrochloride Injection USP, 10 mg/mL by Sagent Pharmaceuticals: Recall – Due to Potential Lack of Sterility Assurance
AUDIENCE: Patient, Health Professional, Risk Manager, Pharmacy
ISSUE: Sagent Pharmaceuticals is recalling three lots of phenylephrine hydrochloride injection USP, 10 mg/mL due to potentially loose crimped vial overseals. A non-integral crimped vial overseal 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 product, while remote, cannot be eliminated. To date, Sagent has not received reports of any adverse events associated with this issue.
For more information about this recall, click on the red button “Read Recall” below.
BACKGROUND: 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.
RECOMMENDATIONS:
- Distributors/retailers that have product which is being recalled should stop using product and return the recalled product.
- Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.
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Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report online.
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.
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