Reported Nov 8, 2023 · Terminated
Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 5mg/6.25mg, 100-count Bottle, RX only, Manufactured by:…
Glenmark Pharmaceuticals Inc., USA
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Glenmark Pharmaceuticals Inc., USA · 750 Corporate Dr · Mahwah, NJ · 07430-2009
Is this the product you have?
- Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 5mg/6.25mg, 100-count Bottle, RX only
- Manufactured byGlenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India
- Manufactured forGlenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC 68462-879-01
- Lot codes and dates
Lot# 17212352Exp 11/31/2023
- Amount recalled
- 480 100-count bottles
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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