D-1422-2015 Class III Terminated
FDA drug recall D-1422-2015 was initiated by Mutual Pharmaceutical Company, Inc. on July 16, 2015 and is designated Class III. Reason for recall: Chemical Contamination; benzophenone leached from the product label varnish The recall status is terminated (terminated October 13, 2016). Affected quantity: 63,975 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- September 16, 2015
- Initiation Date
- July 16, 2015
- Termination Date
- October 13, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 63,975 bottles
Product Description
Felodipine Extended-Release Tablets, 10 mg, 100 count bottles, Rx only, Mutual Pharmaceutical Co Inc., Philadelphia, PA --- NDC 53489-370-01
Reason for Recall
Chemical Contamination; benzophenone leached from the product label varnish
Distribution Pattern
Nationwide
Code Information
lot #s: 6667301 & 6667401, exp 11/15 and 6699201, exp 6/16