FDA recall D-0087-2019

Lupin Pharmaceuticals Inc. · Class III · drug

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

Reason for recall

Defective Container: Repetitive complaints received indicating pump not working.

Distribution

Nationwide within the United States

Key facts

Status
Terminated
Initiation date
2018-10-09
Report date
2018-10-31
Termination date
2019-12-16
Voluntary/Mandated
Voluntary: Firm initiated
Location
Baltimore, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0087-2019