D-1444-2014 Class III Terminated
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