FDA recall D-0120-2018

Product

Lorazepam Oral Concentrate, USP, 2 mg/mL, 30 mL bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Branchburg, NJ 08876. Distributed by: Amneal Pharmaceuticals, Glasgow, KY 42141. NDC 65162-687-84

Reason for recall

Defective Delivery System: the dropper measurement markings may be reversed, shifted or missing.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2017-08-03

Report date

2017-12-27

Termination date

2022-09-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Brookhaven, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0120-2018