Telmisartan And Hydrochlorothiazide Tablet
FDA Recall NDC 68462-841
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 Telmisartan And Hydrochlorothiazide (NDC 68462-841). A significant event, classified as Class II, was initiated on Jun 29, 2022 by Glenmark Pharmaceuticals Inc., Usa. The reported reason for this action was: "Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the blister ."
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
Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the blister .
Jun 29, 2022
Aug 17, 2022
N/A
Recall Profile & Regulatory Data
Event ID
90541
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Glenmark Pharmaceuticals Inc., USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
nationwide
Termination Date
Jun 27, 2024
Product Description
Telmisartan and Hydrochlorothiazide Tablets USP, 80 mg/12.5 mg, 30 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot no 2, Phase-2, Pharma Zone, SEZ Pithampur, District Dhar, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc,m USA, Mahwah, NJ 07430, NDC 68462-841-13.
Batch or Lot Expiration Information
Lot# Lots 17210929 & 17210930, Exp Date 05/2023; Lot 17211203, Exp Date 06/2023 & Lots 17211643, 17211646 & 17211649, Exp Date 08/2023
Affected Packages Involved in this Recall
68462-840-13Product
68462-841-13Product
68462-842-13Product
Class II Terminated
Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the blister .
Jun 29, 2022
Aug 17, 2022
72288 units
Recall Profile & Regulatory Data
Event ID
90541
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Glenmark Pharmaceuticals Inc., USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
nationwide
Termination Date
Jun 27, 2024
Product Description
Telmisartan and Hydrochlorothiazide Tablets USP, 80 mg/25 mg, 30 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot no 2, Phase-2, Pharma Zone, SEZ Pithampur, District Dhar, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc, USA, Mahwah, NJ 07430, NDC 68462-842-13.
Batch or Lot Expiration Information
Lot# Lots 17210935 & 17210936., Exp Date 05/2023 Lot 17211206, Exp Date 06/2023 Lots 17211652, 17211655 & 17211658, Exp Date 08/2023
Affected Packages Involved in this Recall
68462-840-13Product
68462-841-13Product
68462-842-13Product
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.
