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ICOSAPENT ETHYL
Wed Jun 18 2025
Reason for Recall
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.
Manufacturers
| Drug | Manufacturer |
|---|---|
| ICOSAPENT ETHYL | Zydus Pharmaceuticals USA Inc. |
Number of affected units
11,616 bottles
Distribution pattern
IL, PA, & MS
UPCs
| UPC |
|---|
| 0370710159276 |
Package NDCs
| NDC |
|---|
| 70710-1738-4 |
| 70710-1592-7 |
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