Drug product
Aurobindo Ranitidine Caspules 150 mg, 60-count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 NDC 59651-144-60
D-0527-2020
Product summary
- Event
- Event 84218
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 45,456 bottles
- Official record key
drug-enforcement:D-0527-2020
Official wording
Reason: CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
Code information: RA1518001-A Jul 2020 RA1518002-A Jul 2020 RA1518005-B Aug 2020 RA1518006-A Aug 2020 RA1519003-A May 2021
Distribution pattern: nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations