Product: 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
Reason for recall: API material used in the manufacturing of the product did not receive regulatory approval prior to release.
Recall initiated: 20180716
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated