D-1305-2022 Class II Terminated
FDA drug recall D-1305-2022 was initiated by Glenmark Pharmaceuticals Inc., USA on Jun 29, 2022 and is designated Class II. Reason for recall: Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the blister . The recall status is terminated (terminated Jun 27, 2024). Affected quantity: 72288 units.
Recall Details
- Product Type
- Drugs
- Report Date
- Aug 17, 2022
- Initiation Date
- Jun 29, 2022
- Termination Date
- Jun 27, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 72288 units
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.
Reason for Recall
Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the blister .
Distribution Pattern
nationwide
Code Information
Lots 17210935 & 17210936., Exp Date 05/2023 Lot 17211206, Exp Date 06/2023 Lots 17211652, 17211655 & 17211658, Exp Date 08/2023
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1305-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026