Drug product
Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIS LTD., Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India, Manufactured for: UNICHEM PHARMACEUTICALS (USA), INC., East Brunswick, NJ 08816, NDC 29300-187-01
D-0301-2026
Product summary
- Event
- Event 98323
- Status
- Ongoing
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0301-2026
Official wording
Reason: cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
Code information: Lot # GBHL24005A, Exp Date: 09/2026
Distribution pattern: US Nationwide and PR.
Derived failure modes
-
Foreign material or chemical contamination
N-Nitroso Bisoprolol impurity
-
Manufacturing or process control
cGMP Deviations