Omega-3-Acid Ethyl Esters Capsules USP, 1 gram* 120-count bottle Rx Only. Manufactured by: Banner Pharmacaps, Inc. High Point, NC 27265. Manufactured for: Teva Pharmaceuticals USA Inc. North Wales, PA 19454 NDC 0093-5401-89

Recall Number: D-1074-2018

Firm: Teva Pharmaceuticals USA

Classification: Class II

Status: Terminated

Report Date: 20180815

Initiation Date: 20180716

Termination Date: 20190328

API material used in the manufacturing of the product did not receive regulatory approval prior to release.

Omega-3-Acid Ethyl Esters Capsules USP, 1 gram* 120-count bottle Rx Only. Manufactured by: Banner Pharmacaps, Inc. High Point, NC 27265. Manufactured for: Teva Pharmaceuticals USA Inc. North Wales, PA 19454 NDC 0093-5401-89