Olanzapine Tablet, Film Coated
FDA Recall NDC 33342-072
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 Olanzapine (NDC 33342-072). A significant event, classified as Class II, was initiated on Nov 25, 2024 by Macleods Pharmaceuticals Limited. The reported reason for this action was: "Failed Impurities/Degradation Specifications"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
November 2024 Class II Recall: Failed Impurities/Degradation Specifications
Recall Number
Class II Ongoing
Failed Impurities/Degradation Specifications
Nov 25, 2024
Dec 25, 2024
15,744 30-count bottles
Recall Profile & Regulatory Data
Event ID
95838
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Macleods Pharmaceuticals Ltd
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540, Manufactured for: Macleods Pharma USA Inc. Princeton, NJ,08540: Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi Himachal Pradesh, INDIA, NDC 33342-067-07.
Batch or Lot Expiration Information
Lot# BOB12318A Exp 07/31/2027
Affected Packages Involved in this Recall
33342-067-07Product
33342-067-44Product
33342-067-12Product
33342-067-11Product
33342-068-07Product
33342-068-44Product
33342-068-12Product
33342-068-11Product
33342-069-07Product
33342-069-44Product
33342-069-12Product
33342-069-11Product
33342-070-07Product
33342-070-15Product
33342-070-12Product
33342-070-44Product
33342-070-11Product
33342-071-07Product
33342-071-15Product
33342-071-12Product
33342-071-44Product
33342-071-11Product
33342-072-07Product
33342-072-15Product
33342-072-12Product
33342-072-44Product
33342-072-11Product
Class II Terminated
cGmp Deviations
Feb 16, 2022
Mar 09, 2022
3672 bottles
Recall Profile & Regulatory Data
Event ID
89607
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Macleods Pharma Usa Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Oct 16, 2023
Product Description
Olanzapine Tablets, USP 10 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA , Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, HImachal Pradesh, India, NDC 33342-070-07.
Batch or Lot Expiration Information
Lot# : BOB42029A, BOB4202B, Exp. Date 09/2022
Affected Packages Involved in this Recall
33342-067-07Product
33342-067-44Product
33342-067-12Product
33342-067-11Product
33342-068-07Product
33342-068-44Product
33342-068-12Product
33342-068-11Product
33342-069-07Product
33342-069-44Product
33342-069-12Product
33342-069-11Product
33342-070-07Product
33342-070-15Product
33342-070-12Product
33342-070-44Product
33342-070-11Product
33342-071-07Product
33342-071-15Product
33342-071-12Product
33342-071-44Product
33342-071-11Product
33342-072-07Product
33342-072-15Product
33342-072-12Product
33342-072-44Product
33342-072-11Product
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.
