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The Harvard Drug Group LLC: Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose blister cards) per carton, Rx only, Packaged and Distribute

DrugsSource: FDA (drug) · Date: 2026-04-29

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
The Harvard Drug Group LLC
Product
Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose blister cards) per carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46288. NDC: 0904-7495-06
Reason / hazard
Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.
Classification
Class II
Status
Ongoing
Distribution / sold at
Nationwide in the USA
Recall initiated
2026-04-09
Code info
Lot#: Lot N02406, Exp 10/31/2026; Lot N02845, Exp 12/31/2026
Product quantity
2,238 5 x 10 unit dose cartons
Voluntary mandated
Voluntary: Firm initiated
City
Dublin
State
OH
Country
United States
Event id
98763
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