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

FDA recall notice · announced March 27, 2019 · Lupin Pharmaceuticals

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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

Reason for recall

Defective Container: Repetitive complaints received indicating pump not working.

Notes

Distribution: 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.
Lot/code information: Lot # K700086, Exp 11/2019
Quantity: 3,200 bottles
Status: Terminated
Products in this recall event:
- 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.) (D-1010-2019)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.