Diltiazem Hydrochloride Extended-Release Capsules, USP 120mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd for: Northstar Rx LLC, Memphis, TN, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh India, NDC 16714-555-01.

Class I - Dangerous

💊 Drugs Recalled: November 1, 2024 Glenmark Pharmaceuticals Inc., USA Prescription Drugs Nationwide

What Should You Do?

Check if you have this product:
Lot #:17222547, Exp. Date, 11/30/2024; 17230598, Exp. Date 02/28/2025
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Glenmark Pharmaceuticals Inc., USA
Reason for Recall:: cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: ongoing

Product Information

Full Description:

Diltiazem Hydrochloride Extended-Release Capsules, USP 120mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd for: Northstar Rx LLC, Memphis, TN, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh India, NDC 16714-555-01.