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Class II · ModerateRecall completed

Telmisartan And Hydrochlorothiazide

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLots 17210935 & 17210936., Exp Date 05/2023 Lot 17211206, Exp Date 06/2023 Lots 17211652, 17211655 & 17211658, Exp Date 08/2023
Where it was soldnationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byGlenmark 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 foreign manufacturer
Brand nameTELMISARTAN AND HYDROCHLOROTHIAZIDE
Generic nameTELMISARTAN AND HYDROCHLOROTHIAZIDE
Active ingredient(s)HYDROCHLOROTHIAZIDE, TELMISARTAN
Distributed by / forGlenmark Pharmaceuticals Inc, USA, Mahwah, NJ 07430
NDC68462-842-13
Show the full FDA record
Full product labelTelmisartan 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.
Recalling firmGlenmark Pharmaceuticals Inc., USA
Distributionnationwide
Quantity72288 units
Recall initiated2022-06-29
Report date2022-08-17
Recall completed2024-06-27
Recall numberD-1305-2022
ClassificationClass II
FDA statusTerminated
Origin on fileMahwah NJ United States

Related

Hydrochlorothiazide recallsRecent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.