FDAClass IIAugust 15, 2018

Omega-3-Acid Ethyl Esters Capsules USP recall

Omega-3-Acid Ethyl Esters Capsules USP, 1 gram* 120-count bottle Rx Only. Manufactured by: Banner Pharmacaps, Inc. High Point, NC 27265. Manufactured…

Why was Omega-3-Acid Ethyl Esters Capsules USP recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # 150001420A, EXP 2/2019

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…
Recalling firm
Teva Pharmaceuticals USA
Quantity
13,715 120-count bottles
Distribution
Product was distributed throughout the United States
Recall date
August 15, 2018
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls