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
This recall has been terminated (originally issued August 15, 2018).
- 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
- Official Source
- View on FDA website ↗
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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