FDA recall D-1444-2014

X-Gen Pharmaceuticals Inc. · Class III · drug

Product

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.

Reason for recall

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".

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2014-07-17
Report date: 2014-07-30
Termination date: 2015-10-07
Voluntary/Mandated: Voluntary: Firm initiated
Location: Horseheads, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1444-2014