Ativan Injection
FDA Recall NDC 0641-6000
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 Ativan (NDC 0641-6000). 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
301,400 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
Ativan Injection (lorazepam injection, USP), 2mg/mL, 1 mL vial, 25 vials per carton, RX Only, Manufactured by West-Ward Eatontown, NJ 07724, Carton NDC# 0641-6001-25, Vial NDC# 0641-6001-01
Batch or Lot Expiration Information
Lot# 060064Z, Exp. 06/2023
Affected Packages Involved in this Recall
0641-6003-01Product
0641-6003-25Product
0641-6002-01Product
0641-6002-10Product
0641-6001-01Product
0641-6001-25Product
0641-6000-01Product
0641-6000-10Product
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.
