Drug product
Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose blister cards) per carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46288. NDC: 0904-7495-06
D-0493-2026
Product summary
- Event
- Event 98763
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2,238 5 x 10 unit dose cartons
- Official record key
drug-enforcement:D-0493-2026
Official wording
Reason: Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.
Code information: Lot#: Lot N02406, Exp 10/31/2026; Lot N02845, Exp 12/31/2026
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Out of specification