Recalls / Class II
Class IID-1074-2018
Product
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
- Affected lot / code info
- Lot # 150001420A, EXP 2/2019
Why it was recalled
API material used in the manufacturing of the product did not receive regulatory approval prior to release.
Recalling firm
- Firm
- Teva Pharmaceuticals USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1090 Horsham Rd, N/A, North Wales, Pennsylvania 19454-1505
Distribution
- Quantity
- 13,715 120-count bottles
- Distribution pattern
- Product was distributed throughout the United States
Timeline
- Recall initiated
- 2018-07-16
- FDA classified
- 2018-08-08
- Posted by FDA
- 2018-08-15
- Terminated
- 2019-03-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1074-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.