Testosterone Solution
FDA Recall NDC 69097-363
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 Testosterone (NDC 69097-363). A significant event, classified as Class III, was initiated on Jun 12, 2019 by Cipla Usa Inc.. The reported reason for this action was: "Defective Container; actuator may improperly function and affect dose delivery."
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
June 2019 Class III Recall: Defective Container; actuator may improperly function and affect dose delivery.
Recall Number
Class III Terminated
Defective Container; actuator may improperly function and affect dose delivery.
Jun 12, 2019
Jul 10, 2019
1776 bottles
Recall Profile & Regulatory Data
Event ID
83117
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
InvaGen Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Jan 28, 2021
Product Description
Testosterone Topical Solution 30mg of testosterone per pump actuation * each actuation delivers 1.5 mL of solution Total contents: 110 mL to deliver 90 mL, Manufactured by: Cipla Ltd, Verna Goa, India Manufactured for: Cipla USA, Inc., Sunrise, FL 33323 NDC 69097-363-44
Batch or Lot Expiration Information
Lot# Lot GH80480 and GH80481, exp 3/2020
Affected Packages Involved in this Recall
69097-363-44Product
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.
