Reported Aug 15, 2018 · Terminated

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

Teva Pharmaceuticals USA

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Teva Pharmaceuticals USA · 1090 Horsham Rd · North Wales, PA · 19454-1505

Is this the product you have?

    • Omega-3-Acid Ethyl Esters Capsules USP
    • 1 gram* 120-count bottle Rx Only
  • Manufactured byBanner Pharmacaps, Inc. High Point, NC 27265
  • Manufactured forTeva Pharmaceuticals USA Inc. North Wales, PA 19454 NDC 0093-5401-89
Lot codes and dates
    • Lot # 150001420A
    • EXP 2/2019
Amount recalled
13,715 120-count bottles

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Mar 28, 2019 · Data as of Sep 19, 6:33 PM UTC

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