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.
Reported: June 18, 2025 Initiated: May 30, 2025 #D-0497-2025
Product Description
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.
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.
Details
- Recalling Firm
- Zydus Pharmaceuticals (USA) Inc
- Units Affected
- 11,616 bottles
- Distribution
- IL, PA, & MS
- Location
- Pennington, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Zydus Pharmaceuticals (USA) Inc. Units affected: 11,616 bottles.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 18, 2025. Severity: Moderate. Recall number: D-0497-2025.
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