FDA-Drug2014-07-30Class III
Clonidine HCl Injection, 1000 mcg/10 mL (100 mcg/mL),10 mL Single Dose Vial, Rx only, Manufactured for: X-Gen Pharmaceuticals Inc., Big Flats, NY 14814, NDC 39822-2000-1.
X-Gen Pharmaceuticals Inc.
Hazard
Labeling: Label Error On Declared Strength: The side label description incorrectly states "Each mL contains 500 mcg Clonidine Hydrochloride" instead of stating "Each mL contains 100 mcg Clonidine Hydrochloride".
Sold states
Nationwide
Affected count
8,356 vials
Manufactured in
300 Daniel Zenker Drive, Horseheads, NY, United States
Products
Clonidine HCl Injection, 1000 mcg/10 mL (100 mcg/mL),10 mL Single Dose Vial, Rx only, Manufactured for: X-Gen Pharmaceuticals Inc., Big Flats, NY 14814, NDC 39822-2000-1.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1444-2014Don't want to check this manually?
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