Drug & medication recalls Moderate risk

Altaire Homatropaire Homatropine Hyrdobromide Opthalmic Solution recalled over sterility concerns

Recall date
July 2, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Altaire Pharmaceuticals, Inc. recalls Altaire Homatropaire Homatropine Hyrdobromide Opthalmic Solution, USP, 5 %, 5 mL, Sterile, Rx only, Mfd. by: Altaire Ph…
Recall number
D-0455-2020
FDA classification
Class II
Brand / firm
Altaire Pharmaceuticals, Inc.
Sold / distributed
U.S.A. Nationwide

Why it was recalled

Lack of Assurance of Sterility

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Altaire Homatropaire Homatropine Hyrdobromide Opthalmic Solution, USP, 5 %, 5 mL, Sterile, Rx only, Mfd. by: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-192-05

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