Medications & Supplements/Prescription Drugs

West-Ward Lorazepam Injection Recalled for Impurity and Degradation Issues

Agency Publication Date: May 15, 2023

Summary

Hikma Pharmaceuticals USA Inc. has recalled approximately 1,352,475 vials of Lorazepam Injection, USP (2mg/mL) manufactured under the West-Ward brand. The recall was issued after routine testing of retained samples showed elevated levels of a specific impurity known as Related Compound-C, which exceeded safety specifications. There have been no reported incidents or injuries related to this issue to date.

Risk

Injectable medications that contain impurities or degradation products beyond specified limits may not work as intended and could potentially cause unintended adverse health effects in patients.

What You Should Do

This recall involves West-Ward brand Lorazepam Injection, USP, 2mg/mL, sold in 1 mL vials (NDC 0641-6044-01) and packaged in cartons containing 25 vials (NDC 0641-6044-25).
Identify if your product is affected by checking for lot numbers 070086 or 070128, both of which have an expiration date of 07/2023.
Stop using the recalled product immediately.
Contact Hikma Pharmaceuticals USA Inc. or your medical distributor to arrange for the return of any remaining inventory.
If you have health concerns regarding the use of this medication, contact your healthcare provider or pharmacist.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding consumer safety.

Your Remedy Options

Other Action

Manufacturer return

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Lorazepam Injection, USP (2mg/mL)by West-Ward

Variants: 1 mL vial, 25 vials per carton

Lot Numbers:

070086 (Exp. 07/2023)

070128 (Exp. 07/2023)

NDC:

0641-6044-01

0641-6044-25

Manufactured by West-Ward, Eatontown, NJ 07724.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92320

Status: Resolved

Manufacturer: Hikma Pharmaceuticals USA Inc.

Sold By: pharmacies; hospitals

Manufactured In: United States

Units Affected: 1,352,475 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

This recall involves West-Ward brand Lorazepam Injection, USP, 2mg/mL, sold in 1 mL vials (NDC 0641-6044-01) and packaged in cartons containing 25 vials (NDC 0641-6044-25).

Identify if your product is affected by checking for lot numbers 070086 or 070128, both of which have an expiration date of 07/2023.

Stop using the recalled product immediately.

Contact Hikma Pharmaceuticals USA Inc. or your medical distributor to arrange for the return of any remaining inventory.

If you have health concerns regarding the use of this medication, contact your healthcare provider or pharmacist.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding consumer safety.