Lorazepam Concentrate
FDA Recall NDC 65162-687
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 65162-687). A significant event, classified as Class I, was initiated on Aug 03, 2017 by Amneal Pharmaceuticals Llc. The reported reason for this action was: "Defective Delivery System: the dropper measurement markings may be reversed, shifted or missing."
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 I Terminated
Defective Delivery System: the dropper measurement markings may be reversed, shifted or missing.
Aug 03, 2017
Dec 27, 2017
136376 bottles
Recall Profile & Regulatory Data
Event ID
77898
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Amneal Pharmaceuticals of New York, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Sep 07, 2022
Product Description
Lorazepam Oral Concentrate, USP, 2 mg/mL, 30 mL bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Branchburg, NJ 08876. Distributed by: Amneal Pharmaceuticals, Glasgow, KY 42141. NDC 65162-687-84
Batch or Lot Expiration Information
Lot# Lot 06876016A, 06876017A, 06876018A, Exp 08/2018; 06876019A, 06876020A, 06876021A, 06876022A, Exp 09/2018; 06876023A, Exp 11/2018; 06876024A, 06876025A, Exp 12/2018; 06877001A, 06877002A, Exp 02/2019; 06877003A, Exp 03/2019.
Affected Packages Involved in this Recall
65162-687-84Product
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.
