Drug product
Felodipine Extended-Release Tablets, 10 mg, 100 count bottles, Rx only, Mutual Pharmaceutical Co Inc., Philadelphia, PA --- NDC 53489-370-01
D-1422-2015
Product summary
- Event
- Event 71836
- Status
- Terminated
- Classification
- Class III
- Quantity
- 63,975 bottles
- Official record key
drug-enforcement:D-1422-2015
Official wording
Reason: Chemical Contamination; benzophenone leached from the product label varnish
Code information: lot #s: 6667301 & 6667401, exp 11/15 and 6699201, exp 6/16
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Chemical Contamination