Recalls / Class II

Class IID-0528-2020

Product

Aurobindo Ranitidine Capsules 300 mg, 30-count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 NDC 59651-145-30

Affected lot / code info

RA3018001-A Jul 2020 RA3018002-A Jul-2020 RA3018003-A Jul 2020 RA3018004-A Aug 2020 RA3018005-A Aug 2020 RA3018006-A Aug 2020 RA3018007-A Sep 2020 RA3018008-A Sep 2020 RA3018009-A Sep 2020 RA3018010-A Oct 2020 RA3019001-A Jan 2021 RA3019002-A Jan 2021 RA3019003-A May 2021

Why it was recalled

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

Recalling firm

Firm

AuroMedics Pharma LLC

Notification channel

Press Release

Type

Voluntary: Firm initiated

Address

279 Princeton Hightstown Rd, East Windsor, New Jersey 08520-1401

Distribution

Quantity

134,160 bottles

Distribution pattern

nationwide

Timeline

Recall initiated

2019-11-06

FDA classified

2019-11-26

Posted by FDA

2019-12-04

Status

Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0528-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.