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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