October 2018 FDA Recall Testosterone by Lupin Pharmaceuticals Inc.
D-0087-2019 - Defective Container

This Class III drug recall was voluntarily initiated by Lupin Pharmaceuticals Inc. on October 9, 2018 for the product Testosterone. The FDA reported the reason for recall as defective container. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0087-2019

Reason for Recall
Defective Container: Repetitive complaints received indicating pump not working.
Initiated
10-09-2018
Reported
10-31-2018
Quantity
6,752 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81213
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.
Lupin 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 within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-16-2019
Product Description About Product Description
Full technical description of the product.
Testosterone Topical Solution, 30mg/1.5mL, 110mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775 INDIA, NDC 68180-943-11

Batch or Lot Expiration Information

Lot# : K700085, K700087, Exp. November 2019

Affected Packages Involved in this Recall

68180-943-11 Testosterone