FDA Recall Rivastigmine Tartrate

View Recall Number, Date, Reasons, Quantity

FDA Recall Enforcement Reports

The last Recall Enforcement Report for Rivastigmine Tartrate with NDC 55111-354 was initiated on 03-06-2017 as a Class III recall due to cross-contamination with other products -related substances test for rivastigmine tartrate capsules usp, 1.5 mg showed a peak for ranitidine. The latest recall number for this product is D-0649-2017 and the recall is currently terminated as of 12-21-2017 .

Recall Number Initiation Date Report Date Recall Classification Product Quantity Product Description Status
D-0649-201703-06-201704-12-2017Class III1,728 bottlesRIVASTIGMINE Tartrate Capsules, USP, 1.5 mg, 60-count bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally 500-900 India, NDC 55111-352-60Terminated
D-1325-201508-03-201508-19-2015Class II2,952 bottlesRivastigmine Tartrate Capsules, USP 1.5 mg, 60 count bottle, Rx Only, Mfd. By Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-352-60Terminated

What is the Enforcement Report?

All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.