FDAClass IIIApril 20, 2016

Fenofibrate Capsules recall: Labeling Error

Fenofibrate Capsules (Micronized), 200 mg , 30-count Unit Dose Blister Packs per carton, Rx Only, Packaged and Distributed by: American Health Packaging Columbus, Ohio 43217 Carton of 30:NDC 68084-835-32, Individual Dose: NDC 68084-835-33.

Why was Fenofibrate Capsules recalled?

Labeling: Incorrect or Missing Lot and/or Exp Date

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 #142548; Exp. 05/16 Lot #145036; Exp. 10/16 Lot #151170; Exp. 03/17 Lot #152978; Exp. 09/17 Lot #155080; Exp. 01/18.

Product
Fenofibrate Capsules (Micronized), 200 mg , 30-count Unit Dose Blister Packs per carton, Rx Only, Packaged and Distributed by: American Health Packaging Columbus, Ohio 43217 Carton of 30:NDC 68084-835-32, Individual Dose: NDC 68084-835-33.
Recalling firm
Amerisource Health Services
Quantity
5,034 cartons (151,020 capsules)
Distribution
Nationwide
Recall date
April 20, 2016
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls