FDA DrugClass IINotable

FDA Recall: Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose blister cards) per

Date: 2026-04-29
Brand: The Harvard Drug Group LLC
Category: Drug
FDA Class: Class II

Description

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

Hazard

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

Remedy

2,238 5 x 10 unit dose cartons

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