PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: August 17, 2022 Initiated: June 29, 2022 #D-1306-2022

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.

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 .

Details

Distribution
nationwide
Location
Mahwah, NJ

Frequently Asked Questions

What product was recalled?
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.. Recalled by Glenmark Pharmaceuticals Inc., USA.
Why was this product recalled?
Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the blister .
Which agency issued this recall?
This recall was issued by the FDA Drug on August 17, 2022. Severity: Moderate. Recall number: D-1306-2022.