FDA recall D-1074-2018

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.

Distribution

Product was distributed throughout the United States

Key facts

Status

Terminated

Initiation date

2018-07-16

Report date

2018-08-15

Termination date

2019-03-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

North Wales, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1074-2018