D-1010-2019 Class III Terminated
FDA drug recall D-1010-2019 was initiated by Lupin Pharmaceuticals Inc. on March 13, 2019 and is designated Class III. Reason for recall: Defective Container: Repetitive complaints received indicating pump not working. The recall status is terminated (terminated June 26, 2020). Affected quantity: 3,200 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- March 27, 2019
- Initiation Date
- March 13, 2019
- Termination Date
- June 26, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,200 bottles
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
Reason for Recall
Defective Container: Repetitive complaints received indicating pump not working.
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.
Code Information
Lot # K700086, Exp 11/2019