D-1074-2018 Class II Terminated
FDA drug recall D-1074-2018 was initiated by Teva Pharmaceuticals USA on Jul 16, 2018 and is designated Class II. Reason for recall: API material used in the manufacturing of the product did not receive regulatory approval prior to release. The recall status is terminated (terminated Mar 28, 2019). Affected quantity: 13,715 120-count bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Aug 15, 2018
- Initiation Date
- Jul 16, 2018
- Termination Date
- Mar 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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1074-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026