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 # K700086, Exp 11/2019
Where it was sold
Recalled product was distributed to 7 major wholesale/drug chain distributors and 1 supermarket chain that may have further distribute the product throughout 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-1010-2019
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Mar 13, 2019
- FDA report date
- Mar 27, 2019
- Quantity
- 3,200 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-1010-2019, exactly as published.
Show all FDA fields
- City
- Baltimore
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 82392
- Address
- 111 S Calvert St Fl 21ST
- Code information
- Lot # K700086, Exp 11/2019
- Postal code
- 21202-6174
- Report date
- Mar 27, 2019
- Product type
- Drugs
- Recall number
- D-1010-2019
- Classification
- Class III
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Product quantity
- 3,200 bottles
- Termination date
- Jun 26, 2020
- 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
- Recalled product was distributed to 7 major wholesale/drug chain distributors and 1 supermarket chain that may have further distribute the product throughout the United States.
- Recall initiation date
- Mar 13, 2019
- Initial firm notification
- Letter
- Center classification date
- Mar 19, 2019