Why it was recalled
Defective Container; actuator may improperly function and affect dose delivery.
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
Lot numbers, UPCs & expiration codes
Lot GH80480 and GH80481, exp 3/2020
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1454-2019
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jun 12, 2019
- FDA report date
- Jul 10, 2019
- Quantity
- 1776 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- InvaGen Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-1454-2019, exactly as published.
Show all FDA fields
- City
- Central Islip
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 83117
- Address
- 550 S Research Pl
- Code information
- Lot GH80480 and GH80481, exp 3/2020
- Postal code
- 11722-4415
- Report date
- Jul 10, 2019
- Product type
- Drugs
- Recall number
- D-1454-2019
- Classification
- Class III
- Recalling firm
- InvaGen Pharmaceuticals, Inc.
- Product quantity
- 1776 bottles
- Termination date
- Jan 28, 2021
- Reason for recall
- Defective Container; actuator may improperly function and affect dose delivery.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Jun 12, 2019
- Initial firm notification
- Letter
- Center classification date
- Jul 3, 2019