Drug 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
D-0528-2020
Product summary
- Event
- Event 84218
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 134,160 bottles
- Official record key
drug-enforcement:D-0528-2020
Official wording
Reason: CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
Code information: 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
Distribution pattern: nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations