DILTIAZEM HYDROCHLORIDE Recall D-0097-2025
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.
DILTIAZEM HYDROCHLORIDE Recall D-0097-2025 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0097-2025 |
| Event ID | 95660 |
| Brand | DILTIAZEM HYDROCHLORIDE |
| Generic Name | DILTIAZEM HYDROCHLORIDE |
| Manufacturer | DILTIAZEM HYDROCHLORIDE |
| Original Package? | 1 |
| Active Substance | DILTIAZEM HYDROCHLORIDE |
| Drug Route | ORAL |
| Distribution | Nationwide in the USA |
| Quantity | 4704 bottles |
| Recall Reason | cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit. |
| Drug Classification | Class II |
| Drug Code Info | 20241211 |
| Product NDC | 16714-553 16714-554 16714-555 |
| Drug UPC | 0316714554013 0316714553016 0316714555010 |
| Recall Initiation Date | 20241101 |
| Report Date | 20241211 |
| Classification Date | 20241203 |
| Address | 750 Corporate Dr Mahwah, NJ 07430-2009 United States |
| Recalling Firm | Glenmark Pharmaceuticals Inc., USA |
| Initial Notification | Letter |
| Unique Ingredient Identifier | OLH94387TE |
| Drug Application Number | ANDA212317 |
| Structured Product Labeling (SPL ID) | a11626b3-d7a9-43b0-85d4-38a582acd661 |
| Structured Product Labeling (SPL Set ID) | e2511ffe-5821-4f64-a469-f8ef9618b1b5 |
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