Why it was recalled
API material used in the manufacturing of the product did not receive regulatory approval prior to release.
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
Lot numbers, UPCs & expiration codes
Lot # 150001420A, EXP 2/2019
Where it was sold
Product was distributed throughout the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1074-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 16, 2018
- FDA report date
- Aug 15, 2018
- Quantity
- 13,715 120-count bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-1074-2018, exactly as published.
Show all FDA fields
- City
- North Wales
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 80550
- Address
- 1090 Horsham Rd
- Code information
- Lot # 150001420A, EXP 2/2019
- Postal code
- 19454-1505
- Report date
- Aug 15, 2018
- Product type
- Drugs
- Recall number
- D-1074-2018
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 13,715 120-count bottles
- Termination date
- Mar 28, 2019
- Reason for recall
- API material used in the manufacturing of the product did not receive regulatory approval prior to release.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Product was distributed throughout the United States
- Recall initiation date
- Jul 16, 2018
- Initial firm notification
- Letter
- Center classification date
- Aug 8, 2018