Drug product
Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, packaged as (a) 30-count bottles, NDC-68462-878-30; (b) 100-count bottle, NDC-68462-878-01; (c) 500-count bottles, NDC-68462-878-05; Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, Inda. Manufactured for: Glenmark Pharmaceuticals, Inc., USA, Mahwah, NJ 07430.
D-0199-2026
Product summary
- Event
- Event 98036
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 11,136 bottles
- Official record key
drug-enforcement:D-0199-2026
Official wording
Reason: Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
Code information: Lot #: (a): Lot 17232401, exp 11/2025; Lot 17240974, exp 05/2026 (b): Lot 17232401, exp 11/2025; Lot 17240974, exp 05/2026 (c): Lot 17232401, exp 11/2025; Lot 17240974, exp 05/2026
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Unknown
Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe