Drug & medication recalls Moderate risk

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

Recall date
September 28, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0085-2018
FDA classification
Class II
Brand / firm
Leading Pharma, LLC
Sold / distributed
Nationwide in the USA

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Lorazepam Tablets, USP CIV, 0.5 mg, 500-count bottle, Rx Only, Manufactured by: Leading Pharma, LLC Fairfield, NJ 07004 NDC 69315-904-05

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