The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0576-2023·Announced 2023-05-24

Lorazepam Injection Vials Recalled Due to Manufacturing Quality Control Failures

RemedyRepack Inc. is recalling 9,038 vials of Lorazepam Injection due to discontinuation of the manufacturer's quality control program. The product may not meet specified identity, strength, quality, and purity standards.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of an injectable pharmaceutical drug with manufacturing deviations affecting product identity, strength, quality, and purity—a high-risk situation for injectable medication. No hospitalizations or reported injuries are stated in the recall notice, consistent with the rubric criterion of risk-of-harm products where injury has not yet been reported.

Plain-English summary

RemedyRepack Inc. is recalling 9,038 vials of Lorazepam Injection, 2mg/mL, in single-dose 1mL vials. The recalled product was manufactured by Akorn Lake Forest, IL and repackaged by RemedyRepack Inc., Indiana, PA. Affected vials have multiple lot numbers with expiration dates ranging from May 2023 through April 2025.

The recall was initiated due to manufacturing deviations related to the discontinuation of the company's quality program. This program was designed to ensure that products meet the identity, strength, quality, and purity characteristics they are purported to possess. As a result, there is a potential risk that the recalled vials may not meet their specified quality standards.

The recalled product was distributed to three direct accounts in Pennsylvania.

Healthcare providers or individuals who have this product should contact RemedyRepack Inc. or the FDA for disposal instructions and further information.

The recalled product

Product
LORazepam Injection, 2mg / mL Single Dose vial 1ml vial, Rx Only, MFG Akorn Lake Forest IL 60045, Repackaged by: RemedyRepack Inc., Indiana PA 15701, Source NDC # 17478-0040-01, Remedy NDC 70518-2268-00
Manufacturer
RemedyRepack Inc.
Category
Drug — Injectable Lorazepam
Hazard
Affected units
9,038

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Lot # B2169656-032223
  • B2169663-032223
  • B2169680-032223
  • B2169713-032223
  • B2109085-021423
  • B2109094-021423
  • B2049229-010623
  • B2049235-010623
  • Exp. Date 04/30/2025
  • B2049224-010623
  • B2027905-122222
  • B2027920-122222
  • B2027941-122222
  • B2027968-122222
  • B2027979-122222
  • B2027989-122222
  • B2005343-120922
  • B2005333-120922
  • Exp. Date 03/31/2025
  • B1970782-112122

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 3 recalled by RemedyRepack Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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