Medications & Supplements/Prescription Drugs

Ativan and Lorazepam Injections Recalled for Impurity and Degradation Issues

Agency Publication Date: August 5, 2022

Summary

Hikma Pharmaceuticals USA Inc. is recalling 5,836,650 vials of Ativan (lorazepam) and generic Lorazepam injections. These medications were found to have impurity levels and degradation compounds that exceeded required safety standards during product testing. No incidents or injuries related to this issue have been reported to date. The products were sold nationwide to hospitals, pharmacies, and clinics.

Risk

The drug failed specification testing for total related compounds, meaning the product contains impurities or has degraded over time. Using medication that has degraded or contains excessive impurities may result in reduced effectiveness or unintended health consequences.

What You Should Do

This recall affects Ativan and generic Lorazepam injections (2mg/mL and 4mg/mL) sold in 1 mL vials under the West-Ward and Novaplus brands.
Identify affected vials by checking for NDC numbers 0641-6044-25, 0641-6044-01, 0641-6001-25, 0641-6001-01, 0641-6048-25, 0641-6048-01, 0641-6045-25, or 0641-6045-01. Check the lot number and expiration date printed on the vial or carton. See the Affected Products section below for the full list of affected codes.
Stop using the recalled product.
Contact the manufacturer or your distributor to arrange for the return of any remaining stock.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have additional questions regarding this recall.

Your Remedy Options

Other Action

Hospital and clinical inventory return.

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

Affected Products

Product: Lorazepam Injection, USP (1 mL vial)

Variants: 2mg/mL, 25 vials per carton

Lot Numbers:

060064 (Exp. 06/2023)

070084 (Exp. 07/2023)

070126 (Exp. 07/2023)

080091 (Exp. 08/2023)

080060 (Exp. 08/2023)

NDC:

0641-6044-25

0641-6044-01

Manufactured by West-Ward Eatontown, NJ. Quantity: 4,739,000 vials.

Product: Ativan Injection (lorazepam injection, USP) (1 mL vial)

Variants: 2mg/mL, 25 vials per carton

Lot Numbers:

060064Z (Exp. 06/2023)

NDC:

0641-6001-25

0641-6001-01

Manufactured by West-Ward Eatontown, NJ. Quantity: 301,400 vials.

Product: Lorazepam Injection, USP, Novaplus (1 mL vial)

Variants: 2mg/mL, 25 vials per carton

Lot Numbers:

070088 (Exp. 07/2023)

NDC:

0641-6048-25

0641-6048-01

Manufactured by Hikma Berkeley Heights, NJ. Quantity: 713,550 vials.

Product: Lorazepam Injection, USP, Novaplus (1 mL vial)

Variants: 4mg/mL, 25 vials per carton

Lot Numbers:

070096 (Exp. 07/2023)

NDC:

0641-6045-25

0641-6045-01

Manufactured by Hikma Berkeley Heights, NJ. Quantity: 82,700 vials.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90583

Status: Resolved

Manufacturer: Hikma Pharmaceuticals USA Inc.

Sold By: hospitals; pharmacies; clinics

Manufactured In: United States

Units Affected: 4 products (4,739,000 vials; 301,400 vials; 713,550 vials; 82,700 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 affects Ativan and generic Lorazepam injections (2mg/mL and 4mg/mL) sold in 1 mL vials under the West-Ward and Novaplus brands.

Identify affected vials by checking for NDC numbers 0641-6044-25, 0641-6044-01, 0641-6001-25, 0641-6001-01, 0641-6048-25, 0641-6048-01, 0641-6045-25, or 0641-6045-01. Check the lot number and expiration date printed on the vial or carton. See the Affected Products section below for the full list of affected codes.

Stop using the recalled product.

Contact the manufacturer or your distributor to arrange for the return of any remaining stock.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have additional questions regarding this recall.

Affected Products

Product: Lorazepam Injection, USP (1 mL vial)

Variants: 2mg/mL, 25 vials per carton

Lot Numbers:

060064 (Exp. 06/2023)

070084 (Exp. 07/2023)

070126 (Exp. 07/2023)

080091 (Exp. 08/2023)

080060 (Exp. 08/2023)

NDC:

0641-6044-25

0641-6044-01

Manufactured by West-Ward Eatontown, NJ. Quantity: 4,739,000 vials.

Product: Ativan Injection (lorazepam injection, USP) (1 mL vial)

Variants: 2mg/mL, 25 vials per carton

Lot Numbers:

060064Z (Exp. 06/2023)

NDC:

0641-6001-25

0641-6001-01

Manufactured by West-Ward Eatontown, NJ. Quantity: 301,400 vials.

Product: Lorazepam Injection, USP, Novaplus (1 mL vial)

Variants: 2mg/mL, 25 vials per carton

Lot Numbers:

070088 (Exp. 07/2023)

NDC:

0641-6048-25

0641-6048-01

Manufactured by Hikma Berkeley Heights, NJ. Quantity: 713,550 vials.

Product: Lorazepam Injection, USP, Novaplus (1 mL vial)

Variants: 4mg/mL, 25 vials per carton

Lot Numbers:

070096 (Exp. 07/2023)

NDC:

0641-6045-25

0641-6045-01

Manufactured by Hikma Berkeley Heights, NJ. Quantity: 82,700 vials.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90583

Status: Resolved

Manufacturer: Hikma Pharmaceuticals USA Inc.

Sold By: hospitals; pharmacies; clinics

Manufactured In: United States

Units Affected: 4 products (4,739,000 vials; 301,400 vials; 713,550 vials; 82,700 vials)

Distributed To: Nationwide