Drug 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
D-1454-2019
Product summary
- Event
- Event 83117
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1776 bottles
- Official record key
drug-enforcement:D-1454-2019
Official wording
Reason: Defective Container; actuator may improperly function and affect dose delivery.
Code information: Lot GH80480 and GH80481, exp 3/2020
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Defective Container; actuator may improperly function and affect dose delivery.