Why it was recalled
Defective Container: Repetitive complaints received indicating pump not working.
Product description
Testosterone Topical Solution, 30mg/1.5mL, 110mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775 INDIA, NDC 68180-943-11
Lot numbers, UPCs & expiration codes
Lot #: K700085, K700087, Exp. November 2019
Where it was sold
Nationwide within the United States
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-0087-2019
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Oct 9, 2018
- FDA report date
- Oct 31, 2018
- Quantity
- 6,752 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0087-2019, exactly as published.
Show all FDA fields
- City
- Baltimore
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 81213
- Address
- 111 S Calvert St Fl 21ST
- Code information
- Lot #: K700085, K700087, Exp. November 2019
- Postal code
- 21202-6174
- Report date
- Oct 31, 2018
- Product type
- Drugs
- Recall number
- D-0087-2019
- Classification
- Class III
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Product quantity
- 6,752 bottles
- Termination date
- Dec 16, 2019
- Reason for recall
- Defective Container: Repetitive complaints received indicating pump not working.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Testosterone Topical Solution, 30mg/1.5mL, 110mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775 INDIA, NDC 68180-943-11
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Oct 9, 2018
- Initial firm notification
- Letter
- Center classification date
- Oct 23, 2018