Drug 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.
D-1084-2019
Product summary
- Event
- Event 82504
- Status
- Terminated
- Classification
- Class III
- Quantity
- 24,966 vials
- Official record key
drug-enforcement:D-1084-2019
Official wording
Reason: 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.
Code information: Lots #: PMXA1917, Exp 09/2020; PMXA1937, PMXA1938, Exp 11/2020;
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Labeling or packaging
Labeling: Label Error