FDA-Drug2019-04-17Class III
Clonidine HCL Injection, 1000 mcg/10mL (100 mcg/mL), 10 ML Single Dose Vial, Rx only, Manufactured for: X-Gen Pharmaceuticals, Big Flats, NY 14814, NDC 39822-2000-1.
X-Gen Pharmaceuticals Inc.
Hazard
Labeling: Label Error on Declared Strength: Side carton panel incorrectly lists the concentration as "500 mcg Clonidine Hydrochloride" rather than the correct concentration of "100 mcg Clonidine Hydrochloride" per mL.
Sold states
Nationwide in the USA.
Affected count
24,966 vials
Manufactured in
300 Daniel Zenker Dr, N/A, Horseheads, NY, United States
Products
Clonidine HCL Injection, 1000 mcg/10mL (100 mcg/mL), 10 ML Single Dose Vial, Rx only, Manufactured for: X-Gen Pharmaceuticals, Big Flats, NY 14814, NDC 39822-2000-1.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1084-2019Don't want to check this manually?
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