AuroMedics Pharma LLC recalls Mirtazapine Tablets, USP, 7.5 mg, 500-count tablets, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 088…

Recall date

November 20, 2019

Source

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

Recall number

D-0637-2020

FDA classification

Class I

Brand / firm

AuroMedics Pharma LLC

Sold / distributed

Nationwide

Why it was recalled

Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contain 500-count bottles of Mirtazapine 15mg tablets labelled as Mirtazapine 7.5 mg tablets.

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

Mirtazapine Tablets, USP, 7.5 mg, 500-count tablets, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 NDC 13107-001-05