Medications & Supplements/Prescription Drugs

PFIZER, INC: Bupivacaine and Lidocaine Injection Recalled for Label Mix-Up

Agency Publication Date: June 1, 2021

Summary

Pfizer, Inc. is recalling 303,007 vials of 0.5% Bupivacaine Hydrochloride Injection and 1% Lidocaine HCl Injection due to a labeling mix-up. Some vials labeled as Bupivacaine may actually contain Lidocaine, and vice versa. These injectable medications are used for local or regional anesthesia, and a mix-up could lead to a patient receiving the wrong medication or the wrong concentration, which could result in under-dosing or over-dosing. Consumers should contact their healthcare provider or pharmacist immediately if they have these products.

Risk

A label mix-up can result in the administration of the wrong drug or an incorrect dose, potentially leading to inadequate pain management or serious systemic toxicity if a patient receives a higher-than-intended concentration of anesthetic.

What You Should Do

Check your medical supplies for 0.5% Bupivacaine Hydrochloride Injection (150 mg/30 mL) with NDC 0409-1162-19 (tray NDC 0409-1162-02) and Lot EG6023 (Exp. 07/01/2022).
Check your medical supplies for 1% Lidocaine HCl Injection (300 mg/30 mL) with NDC 0409-4279-16 (tray NDC 0409-4279-02) and Lot EG8933 (Exp. 08/01/2022).
If you identify affected vials, do not use them and quarantine the product immediately.
Contact your healthcare provider or pharmacist for guidance regarding the use of these medications and to discuss alternative treatments.
Return any unused, affected product to the pharmacy or place of purchase for a refund and contact Pfizer, Inc. for further instructions.
For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

Full Refund

Healthcare guidance and refund

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

Affected Products

Product: 0.5% Bupivacaine Hydrochloride Injection, USP, 150 mg/30 mL (5 mg/mL), 30 mL Single-dose Teartop Vials

Model:

NDC 0409-1162-19

NDC 0409-1162-02

Lot Numbers:

EG6023 (Exp. 07/01/2022)

Date Ranges: 07/01/2022

Product: 1% Lidocaine HCl Injection, USP, 300 mg/30 mL (10 mg/mL), 30 mL Single-dose vial

Model:

NDC 0409-4279-16

NDC 0409-4279-02

Lot Numbers:

EG8933 (Exp. 08/01/2022)

Date Ranges: 08/01/2022

Product Images

Product image, Hospira, Inc. Sterile water for injection USP 100 mL

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 87837

Status: Resolved

Manufacturer: PFIZER, INC

Sold By: Hospira, Inc.

Manufactured In: United States

Units Affected: 2 products (163,957 vials; 139,050 vials)

Distributed To: Nationwide

Agency Last Updated: June 10, 2021

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 · FDA Press Release · 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 0.5% Bupivacaine Hydrochloride Injection (150 mg/30 mL) with NDC 0409-1162-19 (tray NDC 0409-1162-02) and Lot EG6023 (Exp. 07/01/2022).

Check your medical supplies for 1% Lidocaine HCl Injection (300 mg/30 mL) with NDC 0409-4279-16 (tray NDC 0409-4279-02) and Lot EG8933 (Exp. 08/01/2022).

If you identify affected vials, do not use them and quarantine the product immediately.

Contact your healthcare provider or pharmacist for guidance regarding the use of these medications and to discuss alternative treatments.

Return any unused, affected product to the pharmacy or place of purchase for a refund and contact Pfizer, Inc. for further instructions.

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

Affected Products

Product: 0.5% Bupivacaine Hydrochloride Injection, USP, 150 mg/30 mL (5 mg/mL), 30 mL Single-dose Teartop Vials

Model:

NDC 0409-1162-19

NDC 0409-1162-02

Lot Numbers:

EG6023 (Exp. 07/01/2022)

Date Ranges: 07/01/2022

Product: 1% Lidocaine HCl Injection, USP, 300 mg/30 mL (10 mg/mL), 30 mL Single-dose vial

Model:

NDC 0409-4279-16

NDC 0409-4279-02

Lot Numbers:

EG8933 (Exp. 08/01/2022)

Date Ranges: 08/01/2022