D-1074-2018 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- August 15, 2018
- Initiation Date
- July 16, 2018
- Termination Date
- March 28, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13,715 120-count bottles
Product Description
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
Reason for Recall
API material used in the manufacturing of the product did not receive regulatory approval prior to release.
Distribution Pattern
Product was distributed throughout the United States
Code Information
Lot # 150001420A, EXP 2/2019