FDA-Drug2017-11-29Class II

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

Leading Pharma, LLC
Hazard

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

Sold states
Nationwide in the USA
Affected count
2952 500-count bottles
Manufactured in
3 Oak Rd, N/A, Fairfield, NJ, United States
Products
Lorazepam Tablets, USP CIV, 0.5 mg, 500-count bottle, Rx Only, Manufactured by: Leading Pharma, LLC Fairfield, NJ 07004 NDC 69315-904-05

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0085-2018

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