FDA recall D-0085-2018

Leading Pharma, LLC · Class II · drug

Product

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

Nationwide in the USA

Key facts

Status
Terminated
Initiation date
2017-09-28
Report date
2017-11-29
Termination date
2020-09-21
Voluntary/Mandated
Voluntary: Firm initiated
Location
Fairfield, NJ, United States

Primary source

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