Diltiazem Hydrochloride Capsule, Extended Release
FDA Recall NDC 47335-678
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Diltiazem Hydrochloride (NDC 47335-678). A significant event, classified as Class II, was initiated on Jan 13, 2023 by Sun Pharmaceutical Industries, Inc.. The reported reason for this action was: "Failed Impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and failed dissolution testing at FDA laboratory."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
January 2023 Class II Recall: Failed Impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and failed dissolution testing at FDA laboratory.
Recall Number
Class II Terminated
Failed Impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and failed dissolution testing at FDA laboratory.
Jan 13, 2023
Feb 08, 2023
Lot # HAC3120A: 6912 Bottles; Lot # HAC3121A: 6792 Bottles; Lot # HAC4460A: 6816 Bottles; Lot # HAD0365A: 6744 Bottles; Lot # HAD1452A: 6840 Bottles
Recall Profile & Regulatory Data
Event ID
91500
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the U.S.
Termination Date
Oct 27, 2023
Product Description
Diltiazem Hydrochloride Extended-Release Capsules, USP, 360 mg; Rx only; 90-count bottles, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389350, Gujarat, India; Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 47335-679-81
Batch or Lot Expiration Information
Lot# : HAC3120A, HAC3121A, Exp. 04/2023; HAC4460A, Exp. 10/2023; HAD0365A, Exp. 12/2023; HAD1452A, Exp. 02/2024.
Affected Packages Involved in this Recall
47335-675-83Product
47335-675-81Product
47335-675-19Product
47335-675-13Product
47335-675-18Product
47335-676-83Product
47335-676-81Product
47335-676-19Product
47335-676-13Product
47335-676-18Product
47335-677-83Product
47335-677-81Product
47335-677-19Product
47335-677-13Product
47335-677-18Product
47335-678-83Product
47335-678-81Product
47335-678-19Product
47335-678-13Product
47335-678-18Product
47335-679-83Product
47335-679-81Product
47335-679-19Product
47335-679-13Product
47335-679-18Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
