The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-0823-2016·Announced 2016-04-20

Amerisource Recalls Fenofibrate Capsules Due to Incorrect or Missing Labeling

Amerisource Health Services is recalling 5,034 cartons of Fenofibrate Capsules (Micronized), 200 mg, due to incorrect or missing lot and expiration dates.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a documentation/labeling error.

Plain-English summary

Amerisource Health Services is voluntarily recalling 5,034 cartons of Fenofibrate Capsules (Micronized), 200 mg, 30-count Unit Dose Blister Packs. The recall is being conducted because the product has incorrect or missing lot and/or expiration dates.

The affected product is packaged and distributed by American Health Packaging in Columbus, Ohio. The recall covers five specific lots: #142548 (Exp. 05/16), #145036 (Exp. 10/16), #151170 (Exp. 03/17), #152978 (Exp. 09/17), and #155080 (Exp. 01/18). The product was distributed nationwide.

This recall is classified as Class III by the FDA, indicating that use of or exposure to the product is not likely to cause adverse health consequences. Consumers and healthcare providers should stop using the affected product and contact their pharmacist or the recalling firm for further instructions.

The recalled product

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.
Manufacturer
Amerisource Health Services
Category
Drug — Prescription Medication
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

  • 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.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Amerisource Health Services under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Amerisource Health Services

See all →

Same hazard · mis labeling

See all →

Similar recalls