Drug product
Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1592-07
D-0295-2026
Product summary
- Event
- Event 98227
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 22,896 bottles
- Official record key
drug-enforcement:D-0295-2026
Official wording
Reason: Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules
Code information: Lot # S2520304, S2520333, Exp 2/28/2027; S2540186, Exp 4/30/2027
Distribution pattern: US Nationwide.
Derived failure modes
-
Potency or specification failure
Subpotent