Drug product
Felodipine Extended-Release Tablets, 5 mg, 100 count bottles, Rx only, Mutual Pharmaceutical Co. Inc., Philadelphia, PA --- NDC 53489-369-01
D-1421-2015
Product summary
- Event
- Event 71836
- Status
- Terminated
- Classification
- Class III
- Quantity
- 97,859 bottles
- Official record key
drug-enforcement:D-1421-2015
Official wording
Reason: Chemical Contamination; benzophenone leached from the product label varnish
Code information: lot #s: 6662801 & 6662901, exp 10/15, 6689601, exp 4/16, 6689701, exp 5/16 and 6708401, 8/16
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Chemical Contamination