Medications & Supplements/Prescription Drugs

HOSPIRA INC, LAKE FOREST: Naloxone Injection Recalled for Potential Particulate Matter on Plunger

Agency Publication Date: June 7, 2018

Summary

Hospira Inc. is recalling 164,860 units of Naloxone Hydrochloride Injection, a medication used to reverse opioid overdoses. The recall was initiated because particulate matter (physical contaminants) was discovered on the syringe plungers. These affected syringes were distributed nationwide across the United States, Puerto Rico, and Guam.

Risk

The presence of particulate matter on the syringe plunger can contaminate the medication during administration. If injected, this could lead to local swelling, irritation of the blood vessels, or more serious complications like an embolism if the particles travel through the bloodstream.

What You Should Do

Check your medicine supply for Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL Carpuject Single-use cartridge syringes.
Verify the lot numbers and expiration dates on the packaging: look for lot 72680LL with expiration date 1DEC2018 (NDC 0409-1782-03) or lot 76510LL with expiration date 1APR2019 (NDC 0409-1782-69).
Immediately stop using any syringes from the affected lots and contact your healthcare provider or pharmacist for guidance on obtaining a safe replacement.
Return any unused product from these specific lots to your pharmacy for a refund and contact Hospira Inc. at 1-800-438-1985 for further instructions regarding the return process.
If you have experienced any adverse health effects after using this product, contact your physician immediately.
For additional questions or to report a complaint, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

Full Refund

Drug recall refund and guidance

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

Affected Products

Product: Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL Carpuject Single-use cartridge syringe, Single unit

Model:

NDC 0409-1782-03

Lot Numbers:

72680LL (Exp. 1DEC2018)

Date Ranges: Expiration date 1DEC2018

Product: Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL Carpuject Single-use cartridge syringe, 10 count box

Model:

NDC 0409-1782-69

Lot Numbers:

76510LL (Exp. 1APR2019)

Date Ranges: Expiration date 1APR2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80167

Status: Resolved

Manufacturer: HOSPIRA INC, LAKE FOREST

Sold By: hospitals; pharmacies

Manufactured In: United States

Units Affected: 164,860 syringes

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 medicine supply for Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL Carpuject Single-use cartridge syringes.

Verify the lot numbers and expiration dates on the packaging: look for lot 72680LL with expiration date 1DEC2018 (NDC 0409-1782-03) or lot 76510LL with expiration date 1APR2019 (NDC 0409-1782-69).

Immediately stop using any syringes from the affected lots and contact your healthcare provider or pharmacist for guidance on obtaining a safe replacement.

Return any unused product from these specific lots to your pharmacy for a refund and contact Hospira Inc. at 1-800-438-1985 for further instructions regarding the return process.

If you have experienced any adverse health effects after using this product, contact your physician immediately.

For additional questions or to report a complaint, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Affected Products

Product: Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL Carpuject Single-use cartridge syringe, Single unit

Model:

NDC 0409-1782-03

Lot Numbers:

72680LL (Exp. 1DEC2018)

Date Ranges: Expiration date 1DEC2018

Product: Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL Carpuject Single-use cartridge syringe, 10 count box

Model:

NDC 0409-1782-69

Lot Numbers:

76510LL (Exp. 1APR2019)

Date Ranges: Expiration date 1APR2019