Recalls / Class III
Class IIID-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
- Brand name
- Testosterone
- Generic name
- Testosterone
- Active ingredient
- Testosterone
- Route
- Topical
- NDC
- 69097-363
- FDA application
- ANDA209533
- Affected lot / code info
- Lot GH80480 and GH80481, exp 3/2020
Why it was recalled
Defective Container; actuator may improperly function and affect dose delivery.
Recalling firm
- Firm
- InvaGen Pharmaceuticals, Inc.
- Manufacturer
- Cipla USA Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 550 S Research Pl, N/A, Central Islip, New York 11722-4415
Distribution
- Quantity
- 1776 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2019-06-12
- FDA classified
- 2019-07-03
- Posted by FDA
- 2019-07-10
- Terminated
- 2021-01-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1454-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.