FDA Recall Clonidine

View Recall Number, Date, Reasons, Quantity

FDA Recall Enforcement Reports

The last Recall Enforcement Report for Clonidine with NDC 39822-2000 was initiated on 03-29-2019 as a Class III recall due to 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. The latest recall number for this product is D-1084-2019 and the recall is currently terminated as of 06-02-2021 .

Recall Number Initiation Date Report Date Recall Classification Product Quantity Product Description Status
D-1084-201903-29-201904-17-2019Class III24,966 vialsClonidine 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.Terminated
D-1444-201407-17-201407-30-2014Class III8,356 vialsClonidine 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.Terminated

What is the Enforcement Report?

All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.