D-0085-2024 Class III Terminated
FDA drug recall D-0085-2024 was initiated by Glenmark Pharmaceuticals Inc., USA on October 20, 2023 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications The recall status is terminated (terminated August 16, 2024). Affected quantity: 480 100-count bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- November 8, 2023
- Initiation Date
- October 20, 2023
- Termination Date
- August 16, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 480 100-count bottles
Product Description
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
Reason for Recall
Failed Impurities/Degradation Specifications
Distribution Pattern
Nationwide in the USA
Code Information
Lot# 17212352, Exp 11/31/2023