FDA-Drug2016-10-19Class II

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

Leiter's Compounding
Hazard

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

Sold states
Nationwide
Affected count
76,315 total units, all products
Manufactured in
17 Great Oaks Blvd, N/A, San Jose, CA, United States
Products
Placebo for Prednisolone Acetate 1%, Oph Suspension, 10 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose, CA

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0017-2017

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