Medications & Supplements/Prescription Drugs

Lorazepam Injection Recalled for Quality and Purity Concerns

Agency Publication Date: May 16, 2023

Summary

RemedyRepack Inc. is recalling 9,038 vials of Lorazepam Injection (2mg/mL). The recall was initiated due to manufacturing deviations and the discontinuation of a quality program intended to ensure the drug meets standards for identity, strength, and purity. Because these safety checks were discontinued, the quality of the medication cannot be guaranteed. The product was distributed to three direct accounts in Pennsylvania.

Risk

The lack of an active quality program means the medication may not possess the correct strength or purity, potentially leading to ineffective treatment or safety issues for patients. No incidents or injuries have been reported to date.

What You Should Do

This recall affects Lorazepam Injection (2mg/mL) single-dose 1mL vials repackaged by RemedyRepack Inc. and labeled with Remedy NDC 70518-2268-00.
To determine if your product is affected, check the lot number and expiration date printed on the vial label. See the Affected Products section below for the full list of affected codes.
Stop using the recalled product. Contact RemedyRepack Inc. 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) for additional questions regarding this recall.

Your Remedy Options

Other Action

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

Affected Products

Product: Lorazepam Injection (2mg/mL)

Variants: 2mg / mL, Single Dose Vial, 1mL Vial

Lot Numbers (54):

B2169656-032223 (Exp. Date 04/30/2025)

B2169663-032223 (Exp. Date 04/30/2025)

B2169680-032223 (Exp. Date 04/30/2025)

B2169713-032223 (Exp. Date 04/30/2025)

B2109085-021423 (Exp. Date 04/30/2025)

B2109094-021423 (Exp. Date 04/30/2025)

B2049229-010623 (Exp. Date 04/30/2025)

B2049235-010623 (Exp. Date 04/30/2025)

B2049224-010623 (Exp. Date 03/31/2025)

B2027905-122222 (Exp. Date 03/31/2025)

B2027920-122222 (Exp. Date 03/31/2025)

B2027941-122222 (Exp. Date 03/31/2025)

B2027968-122222 (Exp. Date 03/31/2025)

B2027979-122222 (Exp. Date 03/31/2025)

B2027989-122222 (Exp. Date 03/31/2025)

B2005343-120922 (Exp. Date 03/31/2025)

B2005333-120922 (Exp. Date 03/31/2025)

B1970782-112122 (Exp. Date 01/31/2025)

B1878510-092922 (Exp. Date 11/30/2024)

B1904609-101322 (Exp. Date 12/31/2024)

B1866210-092222 (Exp. Date 12/31/2024)

B1711316-060222 (Exp. Date 09/30/2024)

B1711328-060222 (Exp. Date 09/30/2024)

B1660244-042522 (Exp. Date 07/31/2024)

B1660288-042522 (Exp. Date 06/30/2024)

B1617673-032422 (Exp. Date 06/30/2024)

B1617737-032422 (Exp. Date 05/31/2024)

B1617744-032422 (Exp. Date 05/31/2024)

B1563407-021422 (Exp. Date 05/31/2024)

B1563498-021422 (Exp. Date 05/31/2024)

B1539158-012822 (Exp. Date 04/30/2024)

B1518050-011222 (Exp. Date 04/30/2024)

B1498175-122921 (Exp. Date 04/30/2024)

B1498194-122921 (Exp. Date 03/31/2024)

B1455889-112621 (Exp. Date 03/31/2024)

B1455918-112621 (Exp. Date 03/31/2024)

B1455901-112621 (Exp. Date 01/31/2024)

B1396346-101421 (Exp. Date 01/31/2024)

B1383216-100721 (Exp. Date 01/31/2024)

B1383214-100721 (Exp. Date 09/30/2023)

B1353451-091721 (Exp. Date 09/30/2023)

B1353463-091721 (Exp. Date 09/30/2023)

B1353480-091721 (Exp. Date 09/30/2023)

B1274069-071521 (Exp. Date 09/30/2023)

B1274079-071521 (Exp. Date 09/30/2023)

B1274052-071521 (Exp. Date 09/30/2023)

B1234313-061721 (Exp. Date 09/30/2023)

B1234339-061721 (Exp. Date 09/30/2023)

B1203592-052721 (Exp. Date 09/30/2023)

B1203608-052721 (Exp. Date 09/30/2023)

NDC:

17478-0040-01

70518-2268-00

Product originally manufactured by Akorn (Lake Forest, IL) and repackaged by RemedyRepack Inc.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92239

Status: Resolved

Manufacturer: RemedyRepack Inc.

Sold By: Direct accounts in PA

Manufactured In: United States

Units Affected: 9,038 vials

Distributed To: Pennsylvania

Agency Last Updated: June 2, 2023

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 Lorazepam Injection (2mg/mL) single-dose 1mL vials repackaged by RemedyRepack Inc. and labeled with Remedy NDC 70518-2268-00.

To determine if your product is affected, check the lot number and expiration date printed on the vial label. See the Affected Products section below for the full list of affected codes.

Stop using the recalled product. Contact RemedyRepack Inc. 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) for additional questions regarding this recall.

Affected Products

Product: Lorazepam Injection (2mg/mL)

Variants: 2mg / mL, Single Dose Vial, 1mL Vial

Lot Numbers (54):

B2169656-032223 (Exp. Date 04/30/2025)

B2169663-032223 (Exp. Date 04/30/2025)

B2169680-032223 (Exp. Date 04/30/2025)

B2169713-032223 (Exp. Date 04/30/2025)

B2109085-021423 (Exp. Date 04/30/2025)

B2109094-021423 (Exp. Date 04/30/2025)

B2049229-010623 (Exp. Date 04/30/2025)

B2049235-010623 (Exp. Date 04/30/2025)

B2049224-010623 (Exp. Date 03/31/2025)

B2027905-122222 (Exp. Date 03/31/2025)

B2027920-122222 (Exp. Date 03/31/2025)

B2027941-122222 (Exp. Date 03/31/2025)

B2027968-122222 (Exp. Date 03/31/2025)

B2027979-122222 (Exp. Date 03/31/2025)

B2027989-122222 (Exp. Date 03/31/2025)

B2005343-120922 (Exp. Date 03/31/2025)

B2005333-120922 (Exp. Date 03/31/2025)

B1970782-112122 (Exp. Date 01/31/2025)

B1878510-092922 (Exp. Date 11/30/2024)

B1904609-101322 (Exp. Date 12/31/2024)

B1866210-092222 (Exp. Date 12/31/2024)

B1711316-060222 (Exp. Date 09/30/2024)

B1711328-060222 (Exp. Date 09/30/2024)

B1660244-042522 (Exp. Date 07/31/2024)

B1660288-042522 (Exp. Date 06/30/2024)

B1617673-032422 (Exp. Date 06/30/2024)

B1617737-032422 (Exp. Date 05/31/2024)

B1617744-032422 (Exp. Date 05/31/2024)

B1563407-021422 (Exp. Date 05/31/2024)

B1563498-021422 (Exp. Date 05/31/2024)

B1539158-012822 (Exp. Date 04/30/2024)

B1518050-011222 (Exp. Date 04/30/2024)

B1498175-122921 (Exp. Date 04/30/2024)

B1498194-122921 (Exp. Date 03/31/2024)

B1455889-112621 (Exp. Date 03/31/2024)

B1455918-112621 (Exp. Date 03/31/2024)

B1455901-112621 (Exp. Date 01/31/2024)

B1396346-101421 (Exp. Date 01/31/2024)

B1383216-100721 (Exp. Date 01/31/2024)

B1383214-100721 (Exp. Date 09/30/2023)

B1353451-091721 (Exp. Date 09/30/2023)

B1353463-091721 (Exp. Date 09/30/2023)

B1353480-091721 (Exp. Date 09/30/2023)

B1274069-071521 (Exp. Date 09/30/2023)

B1274079-071521 (Exp. Date 09/30/2023)

B1274052-071521 (Exp. Date 09/30/2023)

B1234313-061721 (Exp. Date 09/30/2023)

B1234339-061721 (Exp. Date 09/30/2023)

B1203592-052721 (Exp. Date 09/30/2023)

B1203608-052721 (Exp. Date 09/30/2023)

NDC:

17478-0040-01

70518-2268-00

Product originally manufactured by Akorn (Lake Forest, IL) and repackaged by RemedyRepack Inc.