D-1454-2019 Class III Terminated
FDA drug recall D-1454-2019 was initiated by InvaGen Pharmaceuticals, Inc. on June 12, 2019 and is designated Class III. Reason for recall: Defective Container; actuator may improperly function and affect dose delivery. The recall status is terminated (terminated January 28, 2021). Affected quantity: 1776 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- July 10, 2019
- Initiation Date
- June 12, 2019
- Termination Date
- January 28, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1776 bottles
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.
Distribution Pattern
Nationwide
Code Information
Lot GH80480 and GH80481, exp 3/2020