Recalls / Class III
Class IIID-1010-2019
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
- Brand name
- Testosterone
- Generic name
- Testosterone
- Active ingredient
- Testosterone
- Route
- Topical
- NDC
- 68180-943
- FDA application
- ANDA208061
- Affected lot / code info
- Lot # K700086, Exp 11/2019
Why it was recalled
Defective Container: Repetitive complaints received indicating pump not working.
Recalling firm
- Firm
- Lupin Pharmaceuticals Inc.
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 111 S Calvert St Fl 21ST, N/A, Baltimore, Maryland 21202-6174
Distribution
- Quantity
- 3,200 bottles
- 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.
Timeline
- Recall initiated
- 2019-03-13
- FDA classified
- 2019-03-19
- Posted by FDA
- 2019-03-27
- Terminated
- 2020-06-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1010-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.