Amlodipine And Olmesartan Medoxomil Tablet, Film Coated
FDA Recall NDC 33342-191
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 Amlodipine And Olmesartan Medoxomil (NDC 33342-191). A significant event, classified as Class II, was initiated on Feb 15, 2022 by Macleods Pharmaceuticals Limited. The reported reason for this action was: "cGMP deviations"
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
Class II Terminated
cGMP deviations
Feb 15, 2022
Mar 09, 2022
3,672 bottles
Recall Profile & Regulatory Data
Event ID
89600
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Macleods Pharma Usa Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Termination Date
Feb 17, 2023
Product Description
Amlodipine and Olmesartan Medoxomil Tablets, 10 mg /20 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 33342-192-07.
Batch or Lot Expiration Information
Lot# : BAD62101A, Exp 2/2024
Affected Packages Involved in this Recall
33342-190-07Product
33342-190-10Product
33342-190-12Product
33342-190-44Product
33342-191-07Product
33342-191-10Product
33342-191-12Product
33342-191-44Product
33342-192-07Product
33342-192-10Product
33342-192-12Product
33342-192-44Product
33342-193-07Product
33342-193-10Product
33342-193-12Product
33342-193-44Product
Class II Terminated
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Mar 15, 2021
Jun 02, 2021
33 bottles
Recall Profile & Regulatory Data
Event ID
87512
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Cardinal Health Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
FL, GA, SC
Termination Date
Jun 17, 2024
Product Description
Amlodipine and Olmesartan Medoxomil Tablets 10 mg/20 mg 30 Tablets Rx Only NDC 33342-192-07 Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, India
Batch or Lot Expiration Information
Lot# BAD62005A
Affected Packages Involved in this Recall
33342-190-07Product
33342-190-10Product
33342-190-12Product
33342-190-44Product
33342-191-07Product
33342-191-10Product
33342-191-12Product
33342-191-44Product
33342-192-07Product
33342-192-10Product
33342-192-12Product
33342-192-44Product
33342-193-07Product
33342-193-10Product
33342-193-12Product
33342-193-44Product
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.
