Recalls / Class II
Class IID-1306-2022
Product
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.
- Brand name
- Telmisartan And Hydrochlorothiazide
- Generic name
- Telmisartan And Hydrochlorothiazide
- Active ingredients
- Hydrochlorothiazide, Telmisartan
- Route
- Oral
- NDCs
- 68462-840, 68462-841, 68462-842
- FDA application
- ANDA202544
- Affected lot / code info
- Lots 17210929 & 17210930, Exp Date 05/2023; Lot 17211203, Exp Date 06/2023 & Lots 17211643, 17211646 & 17211649, Exp Date 08/2023
Why it was 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 .
Recalling firm
- Firm
- Glenmark Pharmaceuticals Inc., USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 750 Corporate Dr, Mahwah, New Jersey 07430-2009
Distribution
- Distribution pattern
- nationwide
Timeline
- Recall initiated
- 2022-06-29
- FDA classified
- 2022-08-05
- Posted by FDA
- 2022-08-17
- Terminated
- 2024-06-27
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1306-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.