Diltiazem Hydrochloride Capsules Recalled Due to Failed Dissolution Specifications
Glenmark Pharmaceuticals is recalling 6,528 bottles of Diltiazem Hydrochloride Extended-Release Capsules nationwide because dissolution testing found the product does not meet specifications. The FDA has classified this as a Class II recall.
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: This is an FDA Class II recall involving failed dissolution specifications in a prescription drug, representing a risk-of-harm product where injury has not yet been reported. Although no illnesses or adverse events are documented in the source, the quality control failure poses a potential risk to patient health if the medication fails to dissolve and absorb properly.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, distributed nationwide. The recalled product includes 6,528 bottles with lot number 17230304 (expiration 12/31/2024). Diltiazem is a prescription medication used to treat high blood pressure and chest pain.
The recall was initiated because dissolution testing showed out-of-specification results. During long-term stability testing at the 12-month timepoint, the product failed dissolution specifications.
Consumers who have this medication should speak with their pharmacist or healthcare provider about the recall. Do not stop taking the medication without consulting your healthcare provider, as it may be needed to treat a heart condition. Return the recalled medication to your pharmacy for proper disposal.
The recalled product
- Product
- DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
- Brand
- DILTIAZEM HYDROCHLORIDE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug — Cardiovascular Medication
- Hazard
- dissolution-failure
- out-of-specification
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 #: 17230304
- Exp. 12/31/2024.
UPCs (3)
- 0368462562017
- 0368462851012
- 0368462850015
Distribution
Distributed nationwide across the United States.
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