FDA recall D-1421-2015
Mutual Pharmaceutical Company, Inc. · Class III · drug
Product
Felodipine Extended-Release Tablets, 5 mg, 100 count bottles, Rx only, Mutual Pharmaceutical Co. Inc., Philadelphia, PA --- NDC 53489-369-01
Reason for recall
Chemical Contamination; benzophenone leached from the product label varnish
Distribution
Nationwide
Key facts
- Status
- Terminated
- Initiation date
- 2015-07-16
- Report date
- 2015-09-16
- Termination date
- 2016-10-13
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Philadelphia, PA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1421-2015