Diltiazem Hydrochloride extended-release capsules recalled due to failed quality specifications
Sun Pharmaceutical is recalling Diltiazem Hydrochloride Extended-Release Capsules (360 mg) due to failed impurity specifications and dissolution testing found during FDA laboratory evaluation. The recall affects five lot numbers distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 failed impurity specifications and dissolution testing. No illnesses or injuries have been reported. The quality failures represent a risk of harm (potential therapeutic failure or impurity exposure) without documented injury, fitting the High severity criterion.
Plain-English summary
Sun Pharmaceutical Industries Inc is recalling Diltiazem Hydrochloride Extended-Release Capsules, USP, 360 mg. Five lot numbers are affected: HAC3120A (6,912 bottles), HAC3121A (6,792 bottles), HAC4460A (6,816 bottles), HAD0365A (6,744 bottles), and HAD1452A (6,840 bottles). The capsules have been distributed nationwide in the United States.
The recall was initiated because of failed impurity specifications during stability testing and failed dissolution testing at FDA laboratories. Deacetyl Diltiazem Hydrochloride, a degradation product, was found at levels exceeding specifications. The capsules also failed dissolution testing, meaning they did not dissolve properly in the laboratory evaluation.
Pharmacies and healthcare providers may have received these capsules. Patients taking this medication from the affected lots should consult their healthcare provider about their course of action.
The recalled product
- Product
- DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
- Brand
- DILTIAZEM HYDROCHLORIDE
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug
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 (9)
- Lot #: HAC3120A
- HAC3121A
- Exp. 04/2023
- HAC4460A
- Exp. 10/2023
- HAD0365A
- Exp. 12/2023
- HAD1452A
- Exp. 02/2024.
UPCs (5)
- 0347335679830
- 0347335677836
- 0347335676839
- 0347335678833
- 0347335675832
Distribution
Distributed nationwide across the United States.
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