Drug product
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
D-0085-2024
Product summary
- Event
- Event 93252
- Status
- Terminated
- Classification
- Class III
- Quantity
- 480 100-count bottles
- Official record key
drug-enforcement:D-0085-2024
Official wording
Reason: Failed Impurities/Degradation Specifications
Code information: Lot# 17212352, Exp 11/31/2023
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications