PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: July 10, 2019 Initiated: June 12, 2019 #D-1454-2019

Product Description

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.

Details

Units Affected
1776 bottles
Distribution
Nationwide
Location
Central Islip, NY

Frequently Asked Questions

What product was recalled?
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. Recalled by InvaGen Pharmaceuticals, Inc.. Units affected: 1776 bottles.
Why was this product recalled?
Defective Container; actuator may improperly function and affect dose delivery.
Which agency issued this recall?
This recall was issued by the FDA Drug on July 10, 2019. Severity: Low. Recall number: D-1454-2019.