Recalls / Class III

Class IIID-1421-2015

Product

Felodipine Extended-Release Tablets, 5 mg, 100 count bottles, Rx only, Mutual Pharmaceutical Co. Inc., Philadelphia, PA --- NDC 53489-369-01

Affected lot / code info

lot #s: 6662801 & 6662901, exp 10/15, 6689601, exp 4/16, 6689701, exp 5/16 and 6708401, 8/16

Why it was recalled

Chemical Contamination; benzophenone leached from the product label varnish

Recalling firm

Firm

Mutual Pharmaceutical Company, Inc.

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

1100 Orthodox St, N/A, Philadelphia, Pennsylvania 19124-3168

Distribution

Quantity

97,859 bottles

Distribution pattern

Nationwide

Timeline

Recall initiated

2015-07-16

FDA classified

2015-09-09

Posted by FDA

2015-09-16

Terminated

2016-10-13

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1421-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.