Drug product
Icosapent Ethyl Capsules 1 gram, 120 Capsules per Bottle, Rx Only, Manufactured by Doppel Farmaceutici s.r.l., Piacenza, Italy, Distributed by Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1592-7.
D-0497-2025
Product summary
- Event
- Event 96964
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 11,616 bottles
- Official record key
drug-enforcement:D-0497-2025
Official wording
Reason: Failed Tablet/Capsule specifications; a product complaint was reported for burnt or melted capsules. This was determined to be a result of oxidation by leakage of capsule contents.
Code information: Lot #s: B237040, B237041, Exp 10/31/2025
Distribution pattern: IL, PA, & MS
Derived failure modes
-
Unknown
Failed Tablet/Capsule specifications; a product complaint was reported for burnt or melted capsules. This was determined to be a result of oxidation by leakage of capsule contents.