Testosterone Solution
FDA Recall NDC 68180-943
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 Testosterone (NDC 68180-943). A significant event, classified as Class III, was initiated on Mar 13, 2019 by Lupin Pharmaceuticals, Inc.. The reported reason for this action was: "Defective Container: Repetitive complaints received indicating pump not working."
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 III Terminated
Defective Container: Repetitive complaints received indicating pump not working.
Mar 13, 2019
Mar 27, 2019
3,200 bottles
Recall Profile & Regulatory Data
Event ID
82392
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Recalled product was distributed to 7 major wholesale/drug chain distributors and 1 supermarket chain that may have further distribute the product throughout the United States.
Termination Date
Jun 26, 2020
Product Description
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# K700086, Exp 11/2019
Affected Packages Involved in this Recall
68180-943-11Product
Class III Terminated
Defective Container: Repetitive complaints received indicating pump not working.
Oct 09, 2018
Oct 31, 2018
6,752 bottles
Recall Profile & Regulatory Data
Event ID
81213
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Dec 16, 2019
Product Description
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
68180-943-11Product
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.
