Class II
Terminated
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
- Company
- Teva Pharmaceuticals Usa
- Recall Initiated
- July 16, 2018
- Posted
- August 15, 2018
- Recall Number
- D-1074-2018
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 13,715 120-count bottles
- Firm Location
- North Wales, PA, United States
Reason for Recall
API material used in the manufacturing of the product did not receive regulatory approval prior to release.
Distribution
Product was distributed throughout the United States
Lot / Code Info
Lot # 150001420A, EXP 2/2019
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