Drug Recall: 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, Pi
Glenmark Pharmaceuticals Inc., USA · November 1, 2024
Reason for Recall
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Product 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.
Distribution
Nationwide in the USA
States Affected
NATIONWIDE
Quantity Affected
7296 bottles
Source: FDA (openFDA Drug Enforcement)
Recall number: D-0098-2025
Status: ongoing
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