Testosterone Topical Solution, 30mg/1.5mL, 110mL bottles, Rx only, Manufactured for: Lupin Pharma...

FDA Recall #D-1010-2019 — Class III — March 13, 2019

Recall #D-1010-2019 Date: March 13, 2019 Classification: Class III Status: Terminated

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

Reason for Recall

Defective Container: Repetitive complaints received indicating pump not working.

Recalling Firm

Lupin Pharmaceuticals Inc. — Baltimore, MD

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

3,200 bottles

Distribution

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.

Code Information

Lot # K700086, Exp 11/2019

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

Back to All Drug Recalls