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Recall

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 Recall

Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells. Product details: 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

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Agency
FDA
Record ID
D-0493-2026
Canonical
https://claimwatch-mvp.vercel.app/item/the-harvard-drug-group-llc-omega-3-acid-ethyl-esters-capsules-usp-1-gram-50-capsules-5-x-1/

What happened?

Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells. Product details: 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

Who may be affected?

Nationwide in the USA

What should consumers do?

Affected quantity: 2,238 5 x 10 unit dose cartons

Official source

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No. This page is informational. Always confirm eligibility, deadlines, and safety instructions through official sources.

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