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
Reported: November 8, 2023 Initiated: October 20, 2023 #D-0085-2024
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
Details
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Units Affected
- 480 100-count bottles
- Distribution
- Nationwide in the USA
- Location
- Mahwah, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Glenmark Pharmaceuticals Inc., USA. Units affected: 480 100-count bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 8, 2023. Severity: Low. Recall number: D-0085-2024.
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