Drug & medication recalls Moderate risk

Placebo for Prednisolone Acetate 1% recalled over sterility concerns

Recall date
September 20, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Leiter's Compounding recalls Placebo for Prednisolone Acetate 1%, Oph Suspension, 10 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose…
Recall number
D-0017-2017
FDA classification
Class II
Brand / firm
Leiter's Compounding
Sold / distributed
Nationwide

Why it was recalled

Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters

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

What was recalled

Placebo for Prednisolone Acetate 1%, Oph Suspension, 10 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose, CA

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