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.
D-1444-2014
Product summary
- Event
- Event 68729
- Status
- Terminated
- Classification
- Class III
- Quantity
- 8,356 vials
- Official record key
drug-enforcement:D-1444-2014
Official wording
Reason: 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".
Code information: Lot: PLNB1412, Exp 12/15
Distribution pattern: Nationwide
Derived failure modes
-
Labeling or packaging
Labeling: Label Error