FDA-Drug2023-11-08Class III
Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 5mg/6.25mg, 100-count Bottle, RX only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC 68462-879-01
Glenmark Pharmaceuticals Inc., USA
Hazard
Failed Impurities/Degradation Specifications
Sold states
Nationwide in the USA
Affected count
480 100-count bottles
Manufactured in
750 Corporate Dr, N/A, Mahwah, NJ, United States
Products
Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 5mg/6.25mg, 100-count Bottle, RX only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC 68462-879-01
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0085-2024Don't want to check this manually?
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