FDA recall D-1084-2019

Product

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.

Reason for recall

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.

Distribution

Nationwide in the USA.

Key facts

Status

Terminated

Initiation date

2019-03-29

Report date

2019-04-17

Termination date

2021-06-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Horseheads, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1084-2019