FDAClass IIISeptember 16, 2015

Felodipine Extended-Release Tablets recall: Contamination

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

Why was Felodipine Extended-Release Tablets recalled?

Chemical Contamination; benzophenone leached from the product label varnish

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Felodipine Extended-Release Tablets, 5 mg, 100 count bottles, Rx only, Mutual Pharmaceutical Co. Inc., Philadelphia, PA --- NDC 53489-369-01
Recalling firm
Mutual Pharmaceutical Company, Inc.
Quantity
97,859 bottles
Distribution
Nationwide
Recall date
September 16, 2015
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls