DILTIAZEM HYDROCHLORIDE Recall D-0095-2025
Description: Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Rx Only, 100 Capsules, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-562-01.
DILTIAZEM HYDROCHLORIDE Recall D-0095-2025 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0095-2025 |
| 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 | 25584 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 | 68462-562 68462-850 68462-851 |
| Drug UPC | 0368462562017 0368462851012 0368462850015 |
| 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) | 52b392c0-72cb-4a91-8d27-5cacdb8a7778 |
| Structured Product Labeling (SPL Set ID) | fb1606ea-1cff-46fd-b8e5-8135da76436c |
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