FDA-Drug2018-08-15Class II
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
Teva Pharmaceuticals USA
Hazard
API material used in the manufacturing of the product did not receive regulatory approval prior to release.
Sold states
Product was distributed throughout the United States
Affected count
13,715 120-count bottles
Manufactured in
1090 Horsham Rd, N/A, North Wales, PA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1074-2018Don't want to check this manually?
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