Amneal Pharmaceuticals of New York, LLC recalls Lorazepam Oral Concentrate, USP, 2 mg/mL, 30 mL bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Branchburg, NJ…

Recall date

August 3, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0120-2018

FDA classification

Class I

Brand / firm

Amneal Pharmaceuticals of New York, LLC

Sold / distributed

Nationwide

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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