Drug product
Felodipine Extended-Release Tablets, 2.5 mg, 100 count bottles, Rx only, Mutual Pharmaceutical Co. Inc., Philadelphia, PA --- NDC 53489-368-01
D-1420-2015
Product summary
- Event
- Event 71836
- Status
- Terminated
- Classification
- Class III
- Quantity
- 25,272 bottles
- Official record key
drug-enforcement:D-1420-2015
Official wording
Reason: Chemical Contamination; benzophenone leached from the product label varnish
Code information: lot #s: 6669101 & 6669201, exp 12/15 and 6708201 & 6708301, exp 8/16
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Chemical Contamination