Duloxetine
FDA Recall NDC 60429-166
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.
The FDA has identified 2 recorded enforcement report(s) associated with Duloxetine (NDC 60429-166). A significant event, classified as Class II, was initiated on May 13, 2024 by Golden State Medical Supply, Inc.. The reported reason for this action was: "CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit."
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
Class II Terminated
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit.
May 13, 2024
Jul 03, 2024
21,655 (30 count bottle), 34,149 (90 count bottle)
Recall Profile & Regulatory Data
Event ID
94639
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Golden State Medical Supply Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the U.S.
Termination Date
Mar 20, 2025
Product Description
Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, a) 30 capsules bottles, NDC 60429-165-30; b) 90 capsules bottles, NDC 60429-165-90, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Packaged by GSMS, Incorporated, Camarillo, CA 93012.
Batch or Lot Expiration Information
Lot# Lot: a) GS045371, Exp: 01/31/2025; b) GS045910, Exp. 01/31/2025
Affected Packages Involved in this Recall
60429-164-60Product
60429-165-30Product
60429-165-90Product
60429-166-30Product
60429-166-10Product
June 2016 Class III Recall: Labeling; Incorrect or Missing Lot and/or Exp Date; incorrect expiration date on container label is 02/2019, correct expiration date should be 02/2018
Recall Number
Class III Terminated
Labeling; Incorrect or Missing Lot and/or Exp Date; incorrect expiration date on container label is 02/2019, correct expiration date should be 02/2018
Jun 28, 2016
Jul 20, 2016
2077 bottles
Recall Profile & Regulatory Data
Event ID
74558
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Golden State Medical Supply Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide. No foreign distribution.
Termination Date
Nov 28, 2016
Product Description
DULOXETINE Delayed-Release Capsules, USP, 60 mg, 1000 count bottles, Rx only, Manufactured by: Laboratorios del Dr. Esteve, SA, Martorelles, Barcelona --- NDC 60429-166-10
Batch or Lot Expiration Information
Lot# GS011709, GS012352
Affected Packages Involved in this Recall
60429-164-60Product
60429-165-30Product
60429-165-90Product
60429-166-30Product
60429-166-10Product
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.
