June 2019 FDA Recall Testosterone by Invagen Pharmaceuticals, Inc.
D-1454-2019 - Defective Container; actuator may improperly function and affect dose delivery.

This Class III drug recall was voluntarily initiated by Invagen Pharmaceuticals, Inc. on June 12, 2019 for the product Testosterone. The FDA reported the reason for recall as defective container; actuator may improperly function and affect dose delivery.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1454-2019

Reason for Recall
Defective Container; actuator may improperly function and affect dose delivery.
Initiated
06-12-2019
Reported
07-10-2019
Quantity
1776 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83117
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
InvaGen Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-28-2021
Product Description About Product Description
Full technical description of the product.
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

69097-363-44 Testosterone