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FDAFDA · Food and drugs·Recall number D-1306-2022

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.

Published August 17, 2022 · Recall initiated: June 29, 2022

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the blister .

What to do

Voluntary: Firm initiated · Letter

Recall details

Brand
TELMISARTAN AND HYDROCHLOROTHIAZIDE
Manufacturer
Glenmark Pharmaceuticals Inc., USA
Distributor
nationwide
UPC
0368462842133
Lot
Lots 17210929 & 17210930, Exp Date 05/2023; Lot 17211203, Exp Date 06/2023 & Lots 17211643, 17211646 & 17211649, Exp Date 08/2023
Risk classification
Class II
Area (FDA)
drug
Country
United States

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