Olanzapine Tablet, Film Coated
FDA Recall NDC 55111-163
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Olanzapine (NDC 55111-163). A significant event, classified as Class III, was initiated on Oct 13, 2016 by Dr. Reddy's Laboratories Ltd.. The reported reason for this action was: "Failed impurities/degradation specifications: due to out-of-specification result for the Related Substance Compound C (Impurity 6 - N-Oxide at the 18 month stability station."
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
October 2016 Class III Recall: Failed impurities/degradation specifications
Recall Number
Class III Terminated
Failed impurities/degradation specifications: due to out-of-specification result for the Related Substance Compound C (Impurity 6 - N-Oxide at the 18 month stability station.
Oct 13, 2016
Feb 15, 2017
5,904 bottles
Recall Profile & Regulatory Data
Event ID
75442
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide
Termination Date
Jul 24, 2017
Product Description
Olanzapine tablets, USP, 2.5 mg, packaged in a 30-count bottle, Rx only, Mfd: By: Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-163-30
Batch or Lot Expiration Information
Lot# C500202
Affected Packages Involved in this Recall
55111-163-30Product
55111-163-01Product
55111-163-05Product
55111-163-79Product
55111-163-78Product
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.
