Teva Pharmaceuticals USA recalls Omega-3-Acid Ethyl Esters Capsules USP, 1 gram* 120-count bottle Rx Only. Manufactured by: Banner Pharmacaps, Inc. High
Recalled August 15, 2018 · FDA recall D-1074-2018 · Teva Pharmaceuticals USA
Hazard
API material used in the manufacturing of the product did not receive regulatory approval prior to release. · FDA Class II
Units
13,715 120-count bottles
Sold at
Product was distributed throughout the United States
Description
API material used in the manufacturing of the product did not receive regulatory approval prior to release.
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
Manufacturer(s)
Teva Pharmaceuticals USA
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →