FDA-Drug2025-06-18Class II
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.
Zydus Pharmaceuticals (USA) Inc
Hazard
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.
Sold states
IL, PA, & MS
Affected count
11,616 bottles
Manufactured in
73 Route 31 N, Pennington, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0497-2025Don't want to check this manually?
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