Recall Enforment Report D-0822-2016

Recall Details

Multi event Drug Recall Enforcement Report Class III voluntary initiated by Amerisource Health Services, originally initiated on 03-31-2016 for the product Fenofibrate Capsules (Micronized), 134 mg Capsules, 20-count Unit Dose Blister Packs per carton, Rx Only, Packaged and Distributed by: American Health Packaging Columbus, Ohio 43217, Carton of 20: NDC 68084-835-32, Individual Dose: NDC 68084-835-33. The product was recalled due to labeling: incorrect or missing lot and/or exp date. The product was distributed nationwide and the recall is currently terminated.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0822-201603-31-201604-20-2016Class III228 cartons ( 4,560 capsules)Fenofibrate Capsules (Micronized), 134 mg Capsules, 20-count Unit Dose Blister Packs per carton, Rx Only, Packaged and Distributed by: American Health Packaging Columbus, Ohio 43217, Carton of 20: NDC 68084-835-32, Individual Dose: NDC 68084-835-33.Labeling: Incorrect or Missing Lot and/or Exp DateTerminated
D-0823-201603-31-201604-20-2016Class III5,034 cartons (151,020 capsules)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.Labeling: Incorrect or Missing Lot and/or Exp DateTerminated