Recall: D-1010-2019

Class III - Minor Violations

Class IIIClassification

2019-03-13Initiated

TerminatedStatus

Lupin Pharmaceuticals Inc.Firm

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

Defective Container: Repetitive complaints received indicating pump not working.

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.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.