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
Reported: August 15, 2018 Initiated: July 16, 2018 #D-1074-2018
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.
Details
- Recalling Firm
- Teva Pharmaceuticals USA
- Units Affected
- 13,715 120-count bottles
- Distribution
- Product was distributed throughout the United States
- Location
- North Wales, PA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Teva Pharmaceuticals USA. Units affected: 13,715 120-count bottles.
Why was this product recalled? ▼
API material used in the manufacturing of the product did not receive regulatory approval prior to release.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 15, 2018. Severity: Moderate. Recall number: D-1074-2018.
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