Telmisartan And Amlodipine
FDA Recall NDC 68180-199
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.
The FDA has identified 1 recorded enforcement report(s) associated with Telmisartan And Amlodipine (NDC 68180-199). A significant event, classified as Class III, was initiated on Apr 01, 2019 by Lupin Pharmaceuticals, Inc.. The reported reason for this action was: "Failed Impurities/Degradation Specifications; 18 month long term stability study."
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
April 2019 Class III Recall: Failed Impurities/Degradation Specifications; 18 month long term stability study.
Recall Number
Class III Terminated
Failed Impurities/Degradation Specifications; 18 month long term stability study.
Apr 01, 2019
Apr 17, 2019
12,504 bottles
Recall Profile & Regulatory Data
Event ID
82528
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed to 6 wholesalers/ drug chains and 2 mail order pharmacies that may have further distribute the product throughout the United States.
Termination Date
Jul 01, 2020
Product Description
Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablet bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by : Lupin Limited, Goa, INDIA -- NDC 68180-198-06
Batch or Lot Expiration Information
Lot# G705843 Exp. date April, 2019 G707763 Exp. date August, 2019 G800434 Exp. date November, 2019
Affected Packages Involved in this Recall
68180-196-06Product
68180-196-09Product
68180-196-12Product
68180-197-06Product
68180-197-09Product
68180-197-12Product
68180-197-07Product
68180-198-06Product
68180-198-09Product
68180-198-12Product
68180-199-06Product
68180-199-09Product
68180-199-12Product
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.
