Estradiol Patch, Extended Release
FDA Recall NDC 70710-1192
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 Estradiol (NDC 70710-1192). A significant event, classified as Class III, was initiated on May 16, 2024 by Zydus Pharmaceuticals Usa Inc.. The reported reason for this action was: "Failed Impurities/Degradation Specifications."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class III Ongoing
Failed Impurities/Degradation Specifications.
May 16, 2024
Jun 12, 2024
13,440 units
Recall Profile & Regulatory Data
Event ID
94649
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Zydus Pharmaceuticals (USA) Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Product Description
Estradiol Transdermal System, USP (Twice-Weekly) 0.025mg/day, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1191-8
Batch or Lot Expiration Information
Lot# : M311202, Exp. Date 2/25; M311201, Exp. Date 1/25
Affected Packages Involved in this Recall
70710-1191-1Product
70710-1191-8Product
70710-1192-1Product
70710-1192-8Product
70710-1193-1Product
70710-1193-8Product
70710-1194-1Product
70710-1194-8Product
70710-1195-1Product
70710-1195-8Product
Class III Ongoing
Failed Impurities/Degradation Specifications.
May 16, 2024
Jun 12, 2024
21,360 units
Recall Profile & Regulatory Data
Event ID
94649
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Zydus Pharmaceuticals (USA) Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Product Description
Estradiol Transdermal System, USP (Twice-Weekly) 0.0375mg/day, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1192-8
Batch or Lot Expiration Information
Lot# : M310493, Exp. Date 01/2025; M308397, Exp. Date 11/2024; M305337, Exp. Date 10/2024; M400155, Exp. Date 06/2025; M314660, Exp. Date 05/2025
Affected Packages Involved in this Recall
70710-1191-1Product
70710-1191-8Product
70710-1192-1Product
70710-1192-8Product
70710-1193-1Product
70710-1193-8Product
70710-1194-1Product
70710-1194-8Product
70710-1195-1Product
70710-1195-8Product
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.
