Reported Nov 29, 2017 · Terminated

Lorazepam Tablets, USP CIV, 0.5 mg, 500-count bottle, Rx Only, Manufactured by: Leading Pharma, LLC Fairfield, NJ 07004…

Leading Pharma, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Leading Pharma, LLC · 3 Oak Rd · Fairfield, NJ · 07004-2903

Is this the product you have?

  • Lorazepam Tablets, USP CIV, 0.5 mg, 500-count bottle, Rx Only
  • Manufactured byLeading Pharma, LLC Fairfield, NJ 07004 NDC 69315-904-05
Lot codes and dates
  • Lot #E00717
Amount recalled
2952 500-count bottles

Where it was sold

  • Nationwide

Why it was recalled

Labeling: Label Error on Declared Strength. Bottle labeled as 0.5 mg tablets contained 1mg tablets of lorazepam

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Sep 21, 2020 · Data as of Sep 19, 7:15 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.