Recalls / Class III
Class IIID-0085-2024
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
- Brand name
- Bisoprolol Fumarate And Hydrochlorothiazide
- Generic name
- Bisoprolol Fumarate And Hydrochlorothiazide
- Active ingredients
- Bisoprolol Fumarate, Hydrochlorothiazide
- Route
- Oral
- NDCs
- 68462-878, 68462-879, 68462-880
- FDA application
- ANDA215995
- Affected lot / code info
- Lot# 17212352, Exp 11/31/2023
Why it was recalled
Failed Impurities/Degradation Specifications
Recalling firm
- Firm
- Glenmark Pharmaceuticals Inc., USA
- Manufacturer
- GLENMARK PHARMACEUTICALS INC., USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 750 Corporate Dr, N/A, Mahwah, New Jersey 07430-2009
Distribution
- Quantity
- 480 100-count bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-10-20
- FDA classified
- 2023-11-02
- Posted by FDA
- 2023-11-08
- Terminated
- 2024-08-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0085-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.