FDA Issues Recall for Clonidine Hydrochloride Injection

X-Gen Pharmaceuticals Inc. is recalling nearly 25,000 vials of clonidine hydrochloride injection, 1000 mcg/10 mL (100 mcg/mL), because of a labeling error. According to the April 17, 2019, US Food and Drug Administration (FDA) Enforcement Report, the side panel on the carton incorrectly lists the concentration as 500 mcg mcg/mL rather than the correct concentration of 100 mcg/mL.

The recall affects clonidine hydrochloride injection, 1000 mcg/10 mL (100 mcg/mL), 10-mL single-dose vials (NDC 39822-2000-1) from three lots:  PMXA1917 (Exp. 9/20), PMXA1937 (Exp. 11/20), and PMXA1938 (Exp. 11/20). The affected vials were distributed throughout the United States. 

X-Gen Pharmaceuticals voluntarily initiated the recall March 29, 2019. On April 8, 2019, the FDA designed the recall Class III, indicating use of the recalled vials is not likely to cause harm. 

Clonidine hydrochloride injection is a prescription analgesic used in combination with opiates to treat cancer pain that is severe.  

—Jolynn Tumolo