Medications & Supplements/Prescription Drugs

Pfizer Inc.: Hydromorphone Hydrochloride Injection Recalled for Cracked Vials and Non-Sterility

Agency Publication Date: March 14, 2018

Summary

Pfizer has recalled approximately 83,000 vials of Hydromorphone Hydrochloride Injection (hydromorphone) because the glass vials may be cracked or empty. A cracked vial can allow bacteria or other contaminants to enter the medication, compromising its sterility. If a patient is injected with non-sterile medication, it can lead to serious or life-threatening infections. These high-potency vials were distributed nationwide across the United States. Consumers and healthcare providers should immediately stop using the affected lots and contact their pharmacist or healthcare provider for guidance on returning the product for a refund.

Risk

Cracked glass containers compromise the sterile barrier of the injectable medication, which can lead to contamination. Injecting a non-sterile drug product into a patient poses a significant risk of severe infection.

What You Should Do

Check your supply for Hydromorphone Hydrochloride Injection, USP CII, 10 mg/mL (1 mL Single-dose Vial), High Potency Formulation.
For products manufactured for Teva Parenteral Medicines (NDC 0703-0110-01), check for lot numbers 691853F with an expiration date of 9/1/2018, or lot number 700753F with an expiration date of 10/1/2018.
For products under the Hospira brand (NDC 0409-2634-01), check for lot number 71330DD with an expiration date of 11/1/2018.
Immediately stop using any vials that match these NDC and lot numbers.
Contact your healthcare provider or pharmacist for guidance regarding this recall and return any unused product to the place of purchase for a refund.
Contact Pfizer at 1-800-438-1985 or visit their website for further instructions regarding the return process.
For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

Full Refund

Healthcare provider/pharmacist consultation and product return.

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

Affected Products

Product: Hydromorphone Hydrochloride Injection, USP CII, 10 mg/mL (1 mL Single-dose Vial), High Potency Formulation (Teva)

Model:

0703-0110-01

Lot Numbers:

691853F (Exp. 9/1/2018)

700753F (Exp. 10/1/2018)

Date Ranges: 9/1/2018, 10/1/2018

Product: Hydromorphone Hydrochloride Injection, USP CII, 10 mg/mL (1 mL Single-dose Vial), High Potency Formulation (Hospira)

Model:

0409-2634-01

Lot Numbers:

71330DD (Exp. 11/1/2018)

Date Ranges: 11/1/2018

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 79114

Status: Resolved

Manufacturer: Pfizer Inc.

Sold By: Teva Parenteral Medicines, Inc.; Hospira, Inc.

Manufactured In: United States

Units Affected: 2 products (53600 vials; 29, 680 vials)

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 Hydromorphone Hydrochloride Injection, USP CII, 10 mg/mL (1 mL Single-dose Vial), High Potency Formulation.

For products manufactured for Teva Parenteral Medicines (NDC 0703-0110-01), check for lot numbers 691853F with an expiration date of 9/1/2018, or lot number 700753F with an expiration date of 10/1/2018.

For products under the Hospira brand (NDC 0409-2634-01), check for lot number 71330DD with an expiration date of 11/1/2018.

Immediately stop using any vials that match these NDC and lot numbers.

Contact your healthcare provider or pharmacist for guidance regarding this recall and return any unused product to the place of purchase for a refund.

Contact Pfizer at 1-800-438-1985 or visit their website for further instructions regarding the return process.

For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Affected Products

Product: Hydromorphone Hydrochloride Injection, USP CII, 10 mg/mL (1 mL Single-dose Vial), High Potency Formulation (Teva)

Model:

0703-0110-01

Lot Numbers:

691853F (Exp. 9/1/2018)

700753F (Exp. 10/1/2018)

Date Ranges: 9/1/2018, 10/1/2018

Product: Hydromorphone Hydrochloride Injection, USP CII, 10 mg/mL (1 mL Single-dose Vial), High Potency Formulation (Hospira)

Model:

0409-2634-01

Lot Numbers:

71330DD (Exp. 11/1/2018)

Date Ranges: 11/1/2018