Lorazepam Injection
FDA Recall NDC 0641-6049
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Lorazepam (NDC 0641-6049). A significant event, classified as Class II, was initiated on Jul 11, 2022 by Hikma Pharmaceuticals Usa Inc.. The reported reason for this action was: "Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
Jul 11, 2022
Aug 17, 2022
713,550 vials
Recall Profile & Regulatory Data
Event ID
90583
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Hikma Pharmaceuticals USA Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Sep 14, 2023
Product Description
Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novaplus, Manufactured by Hikma Berkeley Heights, NJ 07922. Carton NDC# 0641-6048-25, Vial NDC# 0641-6048-01
Batch or Lot Expiration Information
Lot# 070088, exp. date 07/2023
Affected Packages Involved in this Recall
0641-6048-01Product
0641-6048-25Product
0641-6050-01Product
0641-6050-10Product
0641-6049-01Product
0641-6049-25Product
0641-6051-01Product
0641-6051-10Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
