Drug 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
D-1074-2018
Product summary
- Event
- Event 80550
- Status
- Terminated
- Classification
- Class II
- Quantity
- 13,715 120-count bottles
- Official record key
drug-enforcement:D-1074-2018
Official wording
Reason: API material used in the manufacturing of the product did not receive regulatory approval prior to release.
Code information: Lot # 150001420A, EXP 2/2019
Distribution pattern: Product was distributed throughout the United States
Derived failure modes
-
Unknown
API material used in the manufacturing of the product did not receive regulatory approval prior to release.