Diltiazem Hydrochloride Capsule, Extended Release
FDA Recall NDC 16714-554
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Diltiazem Hydrochloride (NDC 16714-554). A significant event, classified as Class II, was initiated on Nov 01, 2024 by Northstar Rx Llc. The reported reason for this action was: "cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Nov 01, 2024
Dec 11, 2024
7296 bottles
Recall Profile & Regulatory Data
Event ID
95660
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Glenmark Pharmaceuticals Inc., USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
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.
Batch or Lot Expiration Information
Lot# :17222547, Exp. Date, 11/30/2024; 17230598, Exp. Date 02/28/2025
Affected Packages Involved in this Recall
16714-553-01Product
16714-554-01Product
16714-555-01Product
Class II Ongoing
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Nov 01, 2024
Dec 11, 2024
4704 bottles
Recall Profile & Regulatory Data
Event ID
95660
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Glenmark Pharmaceuticals Inc., USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
Diltiazem Hydrochloride Extended-Release Capsules, USP 90mg, 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 16714-554-01.
Batch or Lot Expiration Information
Lot# : 17222452, Exp Date 11/30/2024; 17230607, Exp Date 02/28/2025.
Affected Packages Involved in this Recall
16714-553-01Product
16714-554-01Product
16714-555-01Product
Class II Ongoing
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Nov 01, 2024
Dec 11, 2024
5232 bottles
Recall Profile & Regulatory Data
Event ID
95660
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Glenmark Pharmaceuticals Inc., USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
Diltiazem Hydrochloride Extended-Release Capsules, USP 60 mg, 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 16714-553-01.
Batch or Lot Expiration Information
Lot# : 17222544, Exp 11/30/2024.
Affected Packages Involved in this Recall
16714-553-01Product
16714-554-01Product
16714-555-01Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
