Prescription Drug Recall: Diltiazem Extended-Release Capsules Fail Dissolution Test
Glenmark Pharmaceuticals is recalling 3,264 bottles of Diltiazem Hydrochloride Extended-Release Capsules nationwide due to failure to meet dissolution specifications. The affected lot may not release the medication properly in the body.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II drug recall for a manufacturing defect (failed dissolution specifications) without reported illnesses or injuries. The product represents a risk-of-harm situation affecting drug efficacy in a cardiac medication.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg (100 capsules per bottle, NDC 68462-562-01) because the product failed dissolution specifications. The recall affects lot 17221312 (expiration 5/31/2024) distributed nationwide in the United States.
Diltiazem is a prescription medication used to treat heart conditions and high blood pressure. Dissolution specifications ensure that capsules release the medication at the proper rate for absorption in the body. When capsules fail to meet these specifications, the medication may not be released as intended.
No illnesses or injuries have been reported. Patients should not stop taking their medication without consulting their healthcare provider. Contact your pharmacist or doctor if you have a bottle from the affected lot to discuss your treatment options.
The recalled product
- Product
- DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
- Brand
- DILTIAZEM HYDROCHLORIDE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Hazard
- dissolution-failure
- reduced-efficacy
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 17221312
- Exp. 5/31/2024
UPCs (3)
- 0368462562017
- 0368462851012
- 0368462850015
Distribution
Distributed nationwide across the United States.
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