Medications & Supplements/Prescription Drugs

Sagent Pharmaceuticals Inc: Phenylephrine HCl Injection Recalled for Lack of Assurance of Sterility

Agency Publication Date: March 17, 2021

Summary

Sagent Pharmaceuticals is recalling approximately 3,716 cartons of Phenylephrine HCl Injection (10 mg per mL) because of reports that the vial seals may be loose. This defect means the medication inside may no longer be sterile, which can lead to serious infections if injected into a patient. The affected medicine was distributed across the United States and Puerto Rico in cartons containing 25 single-dose vials.

Risk

A loose vial seal compromises the sterile barrier of the medication, potentially allowing bacteria or other pathogens to contaminate the drug. If a non-sterile product is administered intravenously, it can cause life-threatening infections or sepsis.

What You Should Do

Check your supply for Phenylephrine HCl Injection, USP, 10 mg per mL (1 mL Single-Dose Vials) with NDC number 25021-315-01.
Identify if your product belongs to the affected lots: PHT8IB2 (Exp 08/2022), PHT9IB2 (Exp 08/2022), or PHT1JB2 (Exp 09/2022).
Immediately stop using any product from these affected lots and quarantine the remaining stock to prevent further use.
Contact your healthcare provider or pharmacist for guidance if you have any medical concerns or have recently used this product.
Return any unused vials or cartons to the pharmacy or place of purchase for a refund and contact Sagent Pharmaceuticals at 1-901-N-Roselle-Rd for further instructions.
For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Drug recall refund and consultation

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Phenylephrine HCl Injection, USP, 10 mg per mL (25 x 1 mL Single-Dose Vials per carton)

Model:

NDC: 25021-315-01

Lot Numbers:

PHT8IB2 (Exp 08/2022)

PHT9IB2 (Exp 08/2022)

PHT1JB2 (Exp 09/2022)

Date Ranges: Expiration 08/2022, Expiration 09/2022

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 87492

Status: Resolved

Manufacturer: Sagent Pharmaceuticals Inc

Sold By: Hospitals; Clinics; Pharmacies

Manufactured In: India, United States

Units Affected: 3716 cartons

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your supply for Phenylephrine HCl Injection, USP, 10 mg per mL (1 mL Single-Dose Vials) with NDC number 25021-315-01.

Identify if your product belongs to the affected lots: PHT8IB2 (Exp 08/2022), PHT9IB2 (Exp 08/2022), or PHT1JB2 (Exp 09/2022).

Immediately stop using any product from these affected lots and quarantine the remaining stock to prevent further use.

Contact your healthcare provider or pharmacist for guidance if you have any medical concerns or have recently used this product.

Return any unused vials or cartons to the pharmacy or place of purchase for a refund and contact Sagent Pharmaceuticals at 1-901-N-Roselle-Rd for further instructions.

For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.