Amlodipine Besylate Tablet
FDA Recall NDC 69097-128
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 Amlodipine Besylate (NDC 69097-128). A significant event, classified as Class III, was initiated on Oct 03, 2018 by Cipla Usa Inc.. The reported reason for this action was: "Subpotent Drug: One lot of product does not meet the product specification for Assay test at 3 month long term stability condition."
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 III Terminated
Subpotent Drug: One lot of product does not meet the product specification for Assay test at 3 month long term stability condition.
Oct 03, 2018
Oct 17, 2018
2880 bottles
Recall Profile & Regulatory Data
Event ID
81099
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
InvaGen Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide with the United States
Termination Date
Jul 13, 2021
Product Description
Amlodipine Besylate USP 10 mg Tablets, 1000-count bottles, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc. 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise FL 33323 UPC 369097128159, NDC 69097-128-15
Batch or Lot Expiration Information
Lot# : GG80218, Exp. 12/2019
Affected Packages Involved in this Recall
69097-126-05Product
69097-126-15Product
69097-127-05Product
69097-127-15Product
69097-128-05Product
69097-128-15Product
3690971281Product
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.
