D-1444-2014 Class III Terminated
FDA drug recall D-1444-2014 was initiated by X-Gen Pharmaceuticals Inc. on July 17, 2014 and is designated Class III. Reason for recall: 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 Hydr… The recall status is terminated (terminated October 7, 2015). Affected quantity: 8,356 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- July 30, 2014
- Initiation Date
- July 17, 2014
- Termination Date
- October 7, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8,356 vials
Product Description
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.
Reason for Recall
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".
Distribution Pattern
Nationwide
Code Information
Lot: PLNB1412, Exp 12/15