FDAFDA · Food and drugs·Recall number D-1074-2018
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
Published August 15, 2018 · Recall initiated: July 16, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
API material used in the manufacturing of the product did not receive regulatory approval prior to release.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Teva Pharmaceuticals USA
- Distributor
- Product was distributed throughout the United States
- Lot
- Lot # 150001420A, EXP 2/2019
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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