Class II
Ongoing
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
This recall is currently active, issued December 4, 2019. It was issued by Auromedics Pharma Llc.
- Company
- Auromedics Pharma Llc
- Recall Initiated
- November 6, 2019
- Posted
- December 4, 2019
- Recall Number
- D-0528-2020
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 134,160 bottles
- Firm Location
- East Windsor, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
Distribution
nationwide
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
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