D-0085-2018 Class II Terminated

Recalled by Leading Pharma, LLC — Fairfield, NJ

Recall Details

Product Type
Drugs
Report Date
November 29, 2017
Initiation Date
September 28, 2017
Termination Date
September 21, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2952 500-count bottles

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

Reason for Recall

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

Distribution Pattern

Nationwide in the USA

Code Information

Lot #E00717