FDA recall D-1454-2019

Product

Testosterone Topical Solution 30mg of testosterone per pump actuation * each actuation delivers 1.5 mL of solution Total contents: 110 mL to deliver 90 mL, Manufactured by: Cipla Ltd, Verna Goa, India Manufactured for: Cipla USA, Inc., Sunrise, FL 33323 NDC 69097-363-44

Reason for recall

Defective Container; actuator may improperly function and affect dose delivery.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2019-06-12

Report date

2019-07-10

Termination date

2021-01-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Central Islip, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1454-2019