Drug product
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
D-1010-2019
Product summary
- Event
- Event 82392
- Status
- Terminated
- Classification
- Class III
- Quantity
- 3,200 bottles
- Official record key
drug-enforcement:D-1010-2019
Official wording
Reason: Defective Container: Repetitive complaints received indicating pump not working.
Code information: Lot # K700086, Exp 11/2019
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.
Derived failure modes
-
Unknown
Defective Container: Repetitive complaints received indicating pump not working.