Lurasidone Hydrochloride Tablet
FDA Recall NDC 47335-684
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Lurasidone Hydrochloride (NDC 47335-684). A significant event, classified as Class II, was initiated on Jan 18, 2024 by Sun Pharmaceutical Industries, Inc.. The reported reason for this action was: "CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment."
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Completed
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Jan 18, 2024
Jan 31, 2024
11,400 bottles
Recall Profile & Regulatory Data
Event ID
93820
Classification
Class II
Enforcement Status
Completed
Recalling Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
Lurasidone Hydrochloride Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191(U.T. of D & NH), INDIA, NDC 47335-639-83.
Batch or Lot Expiration Information
Lot# : DNE0620A Exp. 05/31/2025
Affected Packages Involved in this Recall
47335-578-83Product
47335-578-81Product
47335-578-13Product
47335-684-83Product
47335-684-81Product
47335-684-13Product
47335-639-83Product
47335-639-81Product
47335-639-13Product
47335-685-83Product
47335-685-81Product
47335-685-13Product
47335-579-83Product
47335-579-81Product
47335-579-13Product
Class II Completed
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Jan 18, 2024
Jan 31, 2024
9,408 bottles
Recall Profile & Regulatory Data
Event ID
93820
Classification
Class II
Enforcement Status
Completed
Recalling Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
Lurasidone Hydrochloride Tablets 120mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191(U.T. of D & NH), INDIA, NDC 47335-579-83.
Batch or Lot Expiration Information
Lot# s: DNE0621A Exp. 11/30/2024, DNE0815A Exp. 12/31/2024
Affected Packages Involved in this Recall
47335-578-83Product
47335-578-81Product
47335-578-13Product
47335-684-83Product
47335-684-81Product
47335-684-13Product
47335-639-83Product
47335-639-81Product
47335-639-13Product
47335-685-83Product
47335-685-81Product
47335-685-13Product
47335-579-83Product
47335-579-81Product
47335-579-13Product
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.
