Why it was recalled
Failed Impurities/Degradation Specifications
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
Lot numbers, UPCs & expiration codes
Lot# 17212352, Exp 11/31/2023
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0085-2024
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Oct 20, 2023
- FDA report date
- Nov 8, 2023
- Quantity
- 480 100-count bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
Original FDA data
Every field from FDA enforcement report D-0085-2024, exactly as published.
Show all FDA fields
- City
- Mahwah
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 93252
- Address
- 750 Corporate Dr
- Code information
- Lot# 17212352, Exp 11/31/2023
- Postal code
- 07430-2009
- Report date
- Nov 8, 2023
- Product type
- Drugs
- Recall number
- D-0085-2024
- Classification
- Class III
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
- Product quantity
- 480 100-count bottles
- Termination date
- Aug 16, 2024
- Reason for recall
- Failed Impurities/Degradation Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Oct 20, 2023
- Initial firm notification
- Letter
- Center classification date
- Nov 2, 2023