Medications & Supplements/Prescription Drugs

Heritage Pharmaceuticals, Inc.: Etomidate Injection Recalled for Being Subpotent

Agency Publication Date: March 15, 2019

Summary

Heritage Pharmaceuticals, Inc. is recalling 11,888 units of Etomidate Injection, USP 20 mg/10mL (2mg/mL). This prescription medication is being recalled because it was found to be subpotent, meaning it may not contain the full required amount of the active ingredient. This could lead to a patient receiving an ineffective dose of the medication during critical medical procedures.

Risk

A subpotent drug may fail to provide the intended clinical effect, potentially leading to inadequate sedation or anesthesia in patients. If a patient does not receive the expected amount of medication, it could result in surgical awareness or other complications during medical procedures.

What You Should Do

Check your inventory for Etomidate Injection, USP 20 mg/10mL (2mg/mL) 10 mL Single-Dose Vials with NDC 23155-160-31.
Verify if your product matches one of the following lot numbers and expiration dates: Lot AMA701 (Exp. March 2019), Lot AMA702 (Exp. August 2019), or Lot AMA703 (Exp. August 2019).
If you have an affected product, contact your healthcare provider or pharmacist immediately for guidance.
Return any unused or affected product to the pharmacy or place of purchase for a refund.
Contact Heritage Pharmaceuticals, Inc. at their East Brunswick, New Jersey location for further instructions regarding the return process.
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

Healthcare provider consultation and pharmacy refund.

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

Affected Products

Product: Etomidate Injection, USP 20 mg/10mL (2mg/mL) 10 mL Single-Dose Vial

Model:

NDC 23155-160-31

Lot Numbers:

AMA701 (Exp. March 2019)

AMA702 (Exp. August 2019)

AMA703 (Exp. August 2019)

Date Ranges: Exp. March 2019, Exp August 2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82198

Status: Resolved

Manufacturer: Heritage Pharmaceuticals, Inc.

Manufactured In: United States, India

Units Affected: 11888 units

Distributed To: Nationwide

Agency Last Updated: March 27, 2019

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 inventory for Etomidate Injection, USP 20 mg/10mL (2mg/mL) 10 mL Single-Dose Vials with NDC 23155-160-31.

Verify if your product matches one of the following lot numbers and expiration dates: Lot AMA701 (Exp. March 2019), Lot AMA702 (Exp. August 2019), or Lot AMA703 (Exp. August 2019).

If you have an affected product, contact your healthcare provider or pharmacist immediately for guidance.

Return any unused or affected product to the pharmacy or place of purchase for a refund.

Contact Heritage Pharmaceuticals, Inc. at their East Brunswick, New Jersey location for further instructions regarding the return process.

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