Aurobindo Ranitidine Capsules 150 mg recalled over manufacturing violations

Recall date

November 6, 2019

Source

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

Official notice title

AuroMedics Pharma LLC recalls Aurobindo Ranitidine Capsules 150 mg, 500 count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeto…

Recall number

D-0530-2020

FDA classification

Class II

Brand / firm

AuroMedics Pharma LLC

Sold / distributed

nationwide

Why it was recalled

CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Aurobindo Ranitidine Capsules 150 mg, 500 count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 NDC 59651-144-05