Lorazepam Tablet
FDA Recall NDC 69315-906
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 69315-906). A significant event, classified as Class II, was initiated on Sep 28, 2017 by Leading Pharma, Llc. The reported reason for this action was: "Labeling: Label Error on Declared Strength. Bottle labeled as 0.5 mg tablets contained 1mg tablets of lorazepam"
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
Labeling: Label Error on Declared Strength. Bottle labeled as 0.5 mg tablets contained 1mg tablets of lorazepam
Sep 28, 2017
Nov 29, 2017
2952 500-count bottles
Recall Profile & Regulatory Data
Event ID
78471
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Leading Pharma, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Sep 21, 2020
Product Description
Lorazepam Tablets, USP CIV, 0.5 mg, 500-count bottle, Rx Only, Manufactured by: Leading Pharma, LLC Fairfield, NJ 07004 NDC 69315-904-05
Batch or Lot Expiration Information
Lot# E00717
Affected Packages Involved in this Recall
69315-904-01Product
69315-904-05Product
69315-904-10Product
69315-905-01Product
69315-905-05Product
69315-905-10Product
69315-906-01Product
69315-906-05Product
69315-906-10Product
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.
