D-0087-2019 Class III Terminated

Recalled by Lupin Pharmaceuticals Inc. — Baltimore, MD

FDA drug recall D-0087-2019 was initiated by Lupin Pharmaceuticals Inc. on Oct 9, 2018 and is designated Class III. Reason for recall: Defective Container: Repetitive complaints received indicating pump not working. The recall status is terminated (terminated Dec 16, 2019). Affected quantity: 6,752 bottles.

Recall Details

Product Type
Drugs
Report Date
Oct 31, 2018
Initiation Date
Oct 9, 2018
Termination Date
Dec 16, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6,752 bottles

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.

Distribution Pattern

Nationwide within the United States

Code Information

Lot #: K700085, K700087, Exp. November 2019

Source

Dataset
openFDA drug recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for D-0087-2019
openFDA file date
Oct 23, 2026
Loaded by RegDataLab
Oct 24, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.