FDA Recall D-0528-2020

AuroMedics Pharma LLC · East Windsor, NJ

Class II Ongoing 2381 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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

Lot / code: 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

Quantity: 134,160 bottles

Reason for recall

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

Recall record

Recall number: D-0528-2020
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Press Release
Distribution: nationwide
Recall initiated: 2019-11-06
Classified by FDA Center: 2019-11-26
FDA published: 2019-12-04
Recalling firm: AuroMedics Pharma LLC
Firm location: East Windsor, NJ

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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