Medications & Supplements/Prescription Drugs

Pfizer Inc.: Fentanyl Citrate Injection Recalled for Potential Sterility Issues

Agency Publication Date: August 4, 2020

Summary

Pfizer Inc. is recalling 19,144 vials of Fentanyl Citrate Injection (100 mcg/2 mL) distributed by Hospira, Inc. due to potential loose metal crimps on the vial seals. This defect can compromise the sterile environment of the medication, which is used for pain management and anesthesia. The affected vials were distributed across the United States and Puerto Rico. Consumers and healthcare providers should check for specific lot numbers including 13405DK and 17096DK with expiration dates in July and November 2021.

Risk

A loose seal on a vial can allow bacteria or other contaminants to enter the medication, leading to serious infections. Because this drug is injected directly into the body, lack of sterility poses a significant health risk to patients.

What You Should Do

Check your medical supplies for Fentanyl Citrate Injection, USP 100 mcg Fentanyl/2 mL (50 mcg/mL) in 2 mL single-dose fliptop vials with NDC 0409-9094-12.
Verify the lot information on the packaging: look for Tray lot 13405DK (Vial lot 13-405 DK) with expiration date 1JUL2021, or Tray lot 17096DK (Vial lot 17-096-DK) with expiration date 1NOV2021.
Immediately stop using any vials from the affected lots and isolate them to prevent accidental administration.
Contact your healthcare provider or pharmacist immediately if you have concerns about medication you have already received or to discuss alternative treatments.
Return any unused product from the recalled lots to your pharmacy or place of purchase for a refund.
Contact Pfizer Inc. at their New York headquarters or through the distributor, Hospira, Inc., for specific return instructions and logistics.
For additional questions or to report side effects, 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

Contact healthcare provider or pharmacist; return for refund.

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

Affected Products

Product: Fentanyl Citrate Injection, USP 100 mcg Fentanyl/2 mL (50 mcg/mL) 2 mL Single-dose Fliptop Vials

Model:

NDC 0409-9094-12

Recall #: D-1446-2020

Lot Numbers:

13405DK (Exp. 1JUL2021)

13-405 DK (Exp. 1JUL2021)

17096DK (Exp. 1NOV2021)

17-096-DK (Exp. 1NOV2021)

13-405

17-096-DK

Date Ranges: Expiration 1JUL2021, Expiration 1NOV2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86074

Status: Resolved

Manufacturer: Pfizer Inc.

Sold By: Hospira, Inc.; Hospitals; Pharmacies

Manufactured In: United States

Units Affected: 19,144 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 medical supplies for Fentanyl Citrate Injection, USP 100 mcg Fentanyl/2 mL (50 mcg/mL) in 2 mL single-dose fliptop vials with NDC 0409-9094-12.

Verify the lot information on the packaging: look for Tray lot 13405DK (Vial lot 13-405 DK) with expiration date 1JUL2021, or Tray lot 17096DK (Vial lot 17-096-DK) with expiration date 1NOV2021.

Immediately stop using any vials from the affected lots and isolate them to prevent accidental administration.

Contact your healthcare provider or pharmacist immediately if you have concerns about medication you have already received or to discuss alternative treatments.

Return any unused product from the recalled lots to your pharmacy or place of purchase for a refund.

Contact Pfizer Inc. at their New York headquarters or through the distributor, Hospira, Inc., for specific return instructions and logistics.

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