Published recall report · ImpurityUpdated · 1 yr 9 mo ago
Glenmark Pharmaceuticals Inc., USA recall: 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 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.
Current recall status is unverified. FDA does not update drug-enforcement status after publication. Check the latest official information or ask a pharmacist.
What to do
Check the lot number on your pack against this recall and follow the firm's instructions. Do not stop taking a prescribed medicine without talking to a pharmacist or doctor first.
FDA public enforcement report, opens in a new tabWhich products
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.
- Producer
- Glenmark Pharmaceuticals Inc., USA
- Brand
- DILTIAZEM HYDROCHLORIDE
17222470
- Dates on pack
- Lot #: 17222470, 17230680, 17222547, Exp. Date 11/30/2024; 17230304, Exp. Date, 12/31/2024; 17230598, Exp. Date, 02/2025.
0368462562017
0368462851012
0368462850015
More detail
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
In the news
Reporting from news publishers. Follow the official notice for product advice.
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