Rivastigmine Tartrate Capsule
FDA Recall NDC 55111-355
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Rivastigmine Tartrate (NDC 55111-355). A significant event, classified as Class III, was initiated on Mar 06, 2017 by Dr. Reddy's Laboratories Limited. The reported reason for this action was: "Cross-contamination with other products -Related Substances test for Rivastigmine Tartrate Capsules USP, 1.5 mg showed a peak for Ranitidine."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
March 2017 Class III Recall: Cross-contamination with other products -Related Substances test for Rivastigmine Tartrate Capsules USP, 1.5 mg showed a peak for Ranitidine.
Recall Number
Class III Terminated
Cross-contamination with other products -Related Substances test for Rivastigmine Tartrate Capsules USP, 1.5 mg showed a peak for Ranitidine.
Mar 06, 2017
Apr 12, 2017
1,728 bottles
Recall Profile & Regulatory Data
Event ID
76699
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. nationwide
Termination Date
Dec 21, 2017
Product Description
RIVASTIGMINE Tartrate Capsules, USP, 1.5 mg, 60-count bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally 500-900 India, NDC 55111-352-60
Batch or Lot Expiration Information
Lot# C607323, Exp 10/18
Affected Packages Involved in this Recall
55111-352-30Product
55111-352-60Product
55111-352-01Product
55111-352-05Product
55111-353-30Product
55111-353-60Product
55111-353-01Product
55111-353-05Product
55111-354-30Product
55111-354-60Product
55111-354-01Product
55111-354-05Product
55111-355-30Product
55111-355-60Product
55111-355-01Product
55111-355-05Product
Class II Terminated
Failed Dissolution Specifications
Aug 03, 2015
Aug 19, 2015
2,952 bottles
Recall Profile & Regulatory Data
Event ID
71906
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Mar 24, 2017
Product Description
Rivastigmine Tartrate Capsules, USP 1.5 mg, 60 count bottle, Rx Only, Mfd. By Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-352-60
Batch or Lot Expiration Information
Lot# : C501342; Exp 01/2017
Affected Packages Involved in this Recall
55111-352-30Product
55111-352-60Product
55111-352-01Product
55111-352-05Product
55111-353-30Product
55111-353-60Product
55111-353-01Product
55111-353-05Product
55111-354-30Product
55111-354-60Product
55111-354-01Product
55111-354-05Product
55111-355-30Product
55111-355-60Product
55111-355-01Product
55111-355-05Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
